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Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Primary Purpose

Hemorrhage

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
idarucizumab
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Group A (Bleeding patients)

    • Overt bleeding judged by the physician to require a reversal agent
    • Currently taking dabigatran etexilate
    • At least 18 years of age
    • Written informed consent

  • Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding

    • Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
    • Current treatment with dabigatran
    • At least 18 years of age
    • Written Informed consent.

Exclusion criteria:

  • Group A (Bleeding Patients)

    • Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
    • Patients with no clinical signs of bleeding
    • Contraindications to study medication including known hypersensitivity to the drug or its excipients.

  • Group B (Patients who require emergency surgery or procedure)

    • A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
    • Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Sites / Locations

  • Baptist Health Center for Clinical Research
  • Loma Linda University Medical Center
  • MedStar Washington Hospital Center
  • University of Florida College of Medicine
  • Baptist Medical Center
  • Mayo Clinic Cancer Center
  • Tampa General Hospital
  • St. Joseph's Hospital
  • Northwestern University
  • OSF Saint Francis Medical Center
  • IU Health Methodist Hospital
  • Community Hospital
  • Our Lady of the Lake Regional Medical Center
  • Newton-Wellesley Hospital
  • Genesys Regional Medical Center
  • Henry Ford Allegiance Health
  • Mercy Hospital St. Louis
  • University of Nebraska Medical Center
  • Duke University Medical Center
  • University of Cincinnati
  • Miami Valley Hospital
  • St. Elizabeth Youngstown Hospital
  • St. John Health System Inc
  • St. Mary Medical Center
  • Lankenau Medical Center
  • Medical University of South Carolina
  • Texas Health Research and Education Institute
  • Memorial Hermann Hospital - Texas Medical Center
  • Sentara RMH Medical Center
  • Virginia Commonwealth University
  • Centro Privado de Cardiología
  • Concord Repatriation General Hospital
  • St George Hospital
  • Royal North Shore Hospital
  • Westmead Hospital-Clinical Haematology Dept
  • Flinders Medical Centre
  • St. Vincents Hospital (MEL)
  • KH der Barmherzigen Schwestern Linz
  • Kepler Univ. Klinikum Linz
  • AKH - Medical University of Vienna
  • Wilhelminenspital
  • Aalst - HOSP Onze-Lieve-Vrouw
  • Brussels - UNIV St-Pierre
  • Brussels - UNIV UZ Brussel
  • Brussels - UNIV St-Luc
  • Genk - HOSP ZOL (St-Jan)
  • UZ Leuven
  • Hospital Nossa Senhora de Pompéia
  • St. Paul's Hospital
  • Jewish General Hospital
  • Hamilton General Hospital
  • Juravinski Hospital
  • Fundación Valle del Lili
  • Centro Médico Imbanaco de Cali S.A.
  • Fundación Cardiovascular de Colombia
  • Hospital Pablo Tobón Uribe
  • University Hospital Brno
  • Hospital,Neurology Dept,Ceske Budejovice
  • Hospital Hradec Kralove
  • Regional Hospital Liberec
  • University Hospital Motol
  • Univ. Hospital Kralovske Vinohrady
  • Aarhus Universitetshospital
  • HUS, Kirurginen päivystysosasto P1P, Meilahti, Helsinki
  • Keski-Suomen keskussairaala
  • Oulun yliopistollinen keskussairaala
  • TAYS, Acuta, Tampere
  • TYKS, Akuutti sisätautihoito ASIS, Turku
  • HOP Trousseau
  • HOP Bocage
  • HOP André Mignot
  • HOP Lille, SAMU 59, Lille
  • HOP Dupuytren
  • HOP Herriot
  • HOP Lapeyronie
  • HOP Haut-Lévêque
  • HOP Lyon Sud
  • HOP Nord
  • HOP Sainte Anne, Urgence, Toulon
  • Vivantes Netzwerk für Gesundheit GmbH
  • Universitätsmedizin Greifswald
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Pamela Youde Nethersole Eastern Hospital
  • Prince of Wales Hospital
  • Prince of Wales Hosp, Dept of Med & Therapeutics
  • B.M. Birla Heart research Centre
  • Fortis Escorts Heart Institute
  • St James's Hospital
  • Cork University Hospital
  • Rambam Medical Center
  • Meir Medical Center
  • The Chaim Sheba Medical Center Tel Hashomer
  • Sourasky Medical Center
  • Azienda Ospedaliera Careggi
  • Ospedale S.Maria della Misericordia, AO di Perugia
  • Azienda Unità Sanitaria Locale di Reggio Emilia
  • Policlinico Gemelli
  • Az. Osp. S.Giovanni-Addolorata
  • Japanese Red Cross Nagoya Daini Hospital
  • Ehime Prefectural Central Hospital
  • Fukuoka Tokushukai Medical Center
  • Ogaki Municipal Hospital
  • National Hospital Organization Takasaki General Medical Center
  • Hyogo College of Medicine Hospital
  • National Hospital Organization Kagoshima Medical Center
  • Shonan Kamakura General Hospital
  • National Cerebral and Cardiovascular Center
  • Nippon Medical School Hospital
  • National Hospital Organization Disaster Medical Center
  • Yamagata City Hospital SAISEIKAN
  • Seoul National University Bundang Hospital
  • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Hospital Cardiologica Aguascalientes
  • OLVG, locatie Oosterpark
  • Academisch Medisch Centrum (AMC)
  • Martini Ziekenhuis
  • Maastricht Universitair Medisch Centrum
  • Radboud Universitair Medisch Centrum
  • Erasmus Medisch Centrum
  • Christchurch Hospital
  • Auckland City Hospital
  • Waikato Hospital
  • Middlemore Hospital
  • North Shore Hospital, Takapuna
  • Haukeland Universitetssykehus
  • Vestre Viken HF, Drammen Sykehus
  • Sykehuset Østfold Kalnes
  • Oslo Universitetssykehus HF, Ullevål sykehus
  • Universitetssykehuset Nord-Norge, Tromsø
  • Univ. Clinic Hosp, Bialystok
  • University Clinical Center, Gdansk
  • Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia
  • Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
  • The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
  • Stefan Kardynal Wyszynski Reg.Hosp,Cardiol&IntensUnit,Lublin
  • Independent Public Healthcare, Dept. of Cardiology, Pulawy
  • Central Hosp.Minis.Interior,Dep.Noninvasive Cardiol,Warszawa
  • Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã
  • CHLO, EPE - Hospital S. Francisco Xavier
  • Centro Hospitalar do Porto, EPE
  • Centro Hospitalar São João,EPE
  • City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
  • Military Medical Academy n.a. S. M. Kirov, St. Petersburg
  • National University Hospital
  • Singapore General Hospital
  • Changi General Hospital
  • Dr. D. Adler
  • Dr. Engelbrecht
  • Hospital General Universitario de Alicante
  • Hospital Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital de Bellvitge
  • Hospital General Universitario Gregorio Marañón
  • Hospital Ramón y Cajal
  • Hospital Clínico San Carlos
  • Hospital La Paz
  • Hospital Regional Universitario de Málaga
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Politècnic La Fe
  • Hospital Clínico de Valencia
  • Hospital Álvaro Cunqueiro
  • Hospital Clínico Universitario Lozano Blesa
  • Sahlgrenska US, Göteborg
  • Skånes universitetssjukhus
  • Akademiska sjukhuset
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Far Eastern Memorial Hospital
  • National Taiwan University Hospital
  • Taipe Veterans General Hospital
  • North Hampshire Hospital
  • Royal Liverpool University Hospital
  • Royal London Hospital
  • St George's Hospital
  • Emergency Department, John Radcliffe Hospital, Oxford
  • Southampton General Hospital
  • Musgrove Park Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

idarucizumab

Arm Description

idarucizumab Only 1 treatment, no placebo or comparator

Outcomes

Primary Outcome Measures

Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.

Secondary Outcome Measures

Reversal of aPTT and TT From Central Laboratory
Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Duration of Reversal
Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.
Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively
Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.
Time to Cessation of Bleeding (for Group A Only)
Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.
Cmin,1 of Unbound Sum (Free) Dabigatran
Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.
Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial
Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.

Full Information

First Posted
April 2, 2014
Last Updated
January 3, 2018
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02104947
Brief Title
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
Official Title
A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 6, 2014 (Actual)
Primary Completion Date
July 25, 2016 (Actual)
Study Completion Date
October 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
idarucizumab
Arm Type
Experimental
Arm Description
idarucizumab Only 1 treatment, no placebo or comparator
Intervention Type
Drug
Intervention Name(s)
idarucizumab
Intervention Description
idarucizumab
Primary Outcome Measure Information:
Title
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT
Description
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Time Frame
from the end of the first infusion up to 4 hours after the last infusion on Day 1
Secondary Outcome Measure Information:
Title
Reversal of aPTT and TT From Central Laboratory
Description
Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Time Frame
from the end of the first infusion up to 4 hours after the last infusion on Day 1
Title
Duration of Reversal
Description
Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.
Time Frame
from the first infusion up to 24 hours after the last infusion on Day 1
Title
Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively
Description
Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.
Time Frame
within 24 hours of surgery
Title
Time to Cessation of Bleeding (for Group A Only)
Description
Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.
Time Frame
from the first infusion up to 24 hours after the last infusion on Day 1
Title
Cmin,1 of Unbound Sum (Free) Dabigatran
Description
Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.
Time Frame
Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial
Title
Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial
Description
Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100.
Time Frame
after the first vial of idarucizumab and before the start of second vial on Day1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Group A (Bleeding patients) Overt bleeding judged by the physician to require a reversal agent Currently taking dabigatran etexilate At least 18 years of age Written informed consent Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours. Current treatment with dabigatran At least 18 years of age Written Informed consent. Exclusion criteria: Group A (Bleeding Patients) Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care. Patients with no clinical signs of bleeding Contraindications to study medication including known hypersensitivity to the drug or its excipients. Group B (Patients who require emergency surgery or procedure) A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low. Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2975
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Our Lady of the Lake Regional Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Henry Ford Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
St. Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
St. John Health System Inc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
St. Mary Medical Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Health Research and Education Institute
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Memorial Hermann Hospital - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara RMH Medical Center
City
Harrisonburg
State/Province
Virginia
ZIP/Postal Code
22801
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0401
Country
United States
Facility Name
Centro Privado de Cardiología
City
Tucumán
ZIP/Postal Code
ZC4000
Country
Argentina
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital-Clinical Haematology Dept
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
St. Vincents Hospital (MEL)
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
KH der Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Kepler Univ. Klinikum Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AKH - Medical University of Vienna
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Aalst - HOSP Onze-Lieve-Vrouw
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Brussels - UNIV St-Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Brussels - UNIV UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Brussels - UNIV St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Genk - HOSP ZOL (St-Jan)
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital Nossa Senhora de Pompéia
City
Caxias do Sul
ZIP/Postal Code
95010-005
Country
Brazil
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V1Y 1S1
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Migration Data
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Fundación Valle del Lili
City
Cali
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Centro Médico Imbanaco de Cali S.A.
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Fundación Cardiovascular de Colombia
City
Floridablanca
Country
Colombia
Facility Name
Hospital Pablo Tobón Uribe
City
Medellin
ZIP/Postal Code
50034
Country
Colombia
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Hospital,Neurology Dept,Ceske Budejovice
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Regional Hospital Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
University Hospital Motol
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Univ. Hospital Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Aarhus Universitetshospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
HUS, Kirurginen päivystysosasto P1P, Meilahti, Helsinki
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Keski-Suomen keskussairaala
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Oulun yliopistollinen keskussairaala
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
TAYS, Acuta, Tampere
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
TYKS, Akuutti sisätautihoito ASIS, Turku
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
HOP Trousseau
City
Chambray les tours
ZIP/Postal Code
37170
Country
France
Facility Name
HOP Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
HOP André Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
HOP Lille, SAMU 59, Lille
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
HOP Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
HOP Lapeyronie
City
Montpellier cedex
ZIP/Postal Code
34295
Country
France
Facility Name
HOP Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
HOP Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
HOP Nord
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
HOP Sainte Anne, Urgence, Toulon
City
Toulon
ZIP/Postal Code
83041
Country
France
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Prince of Wales Hosp, Dept of Med & Therapeutics
City
Hong Kong
Country
Hong Kong
Facility Name
B.M. Birla Heart research Centre
City
Kolkatta
ZIP/Postal Code
700027
Country
India
Facility Name
Fortis Escorts Heart Institute
City
New Delhi
ZIP/Postal Code
110025
Country
India
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
DUBLIN 8
Country
Ireland
Facility Name
Cork University Hospital
City
Wilton
Country
Ireland
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
The Chaim Sheba Medical Center Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedale S.Maria della Misericordia, AO di Perugia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Azienda Unità Sanitaria Locale di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Policlinico Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Az. Osp. S.Giovanni-Addolorata
City
Roma
ZIP/Postal Code
00184
Country
Italy
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Aichi, Nagoya
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Ehime Prefectural Central Hospital
City
Ehime, Matsuyama
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Fukuoka Tokushukai Medical Center
City
Fukuoka, Kasuga
ZIP/Postal Code
816-0864
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Gifu, Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Gunma, Takasaki
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Hyogo, Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
National Hospital Organization Kagoshima Medical Center
City
Kagoshima, Kagoshima
ZIP/Postal Code
892-0853
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kanagawa, Kamakura
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Osaka, Suita
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo, Bunkyo-Ku
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center
City
Tokyo, Tachikawa
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
Yamagata City Hospital SAISEIKAN
City
Yamagata, Yamagata
ZIP/Postal Code
990-8533
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St.Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Hospital Cardiologica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20297
Country
Mexico
Facility Name
OLVG, locatie Oosterpark
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
ZIP/Postal Code
6229 ER
Country
Netherlands
Facility Name
Radboud Universitair Medisch Centrum
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Auckland City Hospital
City
Grafton / Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Middlemore Hospital
City
Otahuhu South Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
North Shore Hospital, Takapuna
City
Takapuna Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Facility Name
Vestre Viken HF, Drammen Sykehus
City
Drammen
ZIP/Postal Code
N-3004
Country
Norway
Facility Name
Sykehuset Østfold Kalnes
City
Grålum
ZIP/Postal Code
N-1714
Country
Norway
Facility Name
Oslo Universitetssykehus HF, Ullevål sykehus
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway
Facility Name
Universitetssykehuset Nord-Norge, Tromsø
City
Tromsø
ZIP/Postal Code
N-9038
Country
Norway
Facility Name
Univ. Clinic Hosp, Bialystok
City
Bialystok
ZIP/Postal Code
15276
Country
Poland
Facility Name
University Clinical Center, Gdansk
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia
City
Gdynia
ZIP/Postal Code
81348
Country
Poland
Facility Name
Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
City
Kielce
ZIP/Postal Code
25736
Country
Poland
Facility Name
The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
City
Krakow
ZIP/Postal Code
31202
Country
Poland
Facility Name
Stefan Kardynal Wyszynski Reg.Hosp,Cardiol&IntensUnit,Lublin
City
Lublin
ZIP/Postal Code
20718
Country
Poland
Facility Name
Independent Public Healthcare, Dept. of Cardiology, Pulawy
City
Pulawy
ZIP/Postal Code
24100
Country
Poland
Facility Name
Central Hosp.Minis.Interior,Dep.Noninvasive Cardiol,Warszawa
City
Warszawa
ZIP/Postal Code
02507
Country
Poland
Facility Name
Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã
City
Covilhã
ZIP/Postal Code
6200-251
Country
Portugal
Facility Name
CHLO, EPE - Hospital S. Francisco Xavier
City
Lisboa
ZIP/Postal Code
1495-005
Country
Portugal
Facility Name
Centro Hospitalar do Porto, EPE
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar São João,EPE
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
City
Saint Petersburg
ZIP/Postal Code
199 106
Country
Russian Federation
Facility Name
Military Medical Academy n.a. S. M. Kirov, St. Petersburg
City
St. Petersburg
ZIP/Postal Code
194175
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Dr. D. Adler
City
Sandton
ZIP/Postal Code
2021
Country
South Africa
Facility Name
Dr. Engelbrecht
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Politècnic La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo (Pontevedra)
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Sahlgrenska US, Göteborg
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skånes universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipe Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
North Hampshire Hospital
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1ES
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Emergency Department, John Radcliffe Hospital, Oxford
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Musgrove Park Hospital
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31582135
Citation
Eikelboom JW, van Ryn J, Reilly P, Hylek EM, Elsaesser A, Glund S, Pollack CV, Weitz JI. Dabigatran Reversal With Idarucizumab in Patients With Renal Impairment. J Am Coll Cardiol. 2019 Oct 8;74(14):1760-1768. doi: 10.1016/j.jacc.2019.07.070.
Results Reference
derived
PubMed Identifier
31050868
Citation
Glund S, Coble K, Gansser D, Stangier J, Hoermann K, Pollack CV, Reilly P. Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran. J Thromb Haemost. 2019 Aug;17(8):1319-1328. doi: 10.1111/jth.14476. Epub 2019 Jun 18.
Results Reference
derived
PubMed Identifier
30586692
Citation
Van der Wall SJ, Lopes RD, Aisenberg J, Reilly P, van Ryn J, Glund S, Elsaesser A, Klok FA, Pollack CV Jr, Huisman MV. Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding. Circulation. 2019 Feb 5;139(6):748-756. doi: 10.1161/CIRCULATIONAHA.118.036710. Erratum In: Circulation. 2019 Feb 5;139(6):e36.
Results Reference
derived
PubMed Identifier
28693366
Citation
Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017 Aug 3;377(5):431-441. doi: 10.1056/NEJMoa1707278. Epub 2017 Jul 11.
Results Reference
derived
PubMed Identifier
26095746
Citation
Pollack CV Jr, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kamphuisen PW, Kreuzer J, Levy JH, Sellke FW, Stangier J, Steiner T, Wang B, Kam CW, Weitz JI. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015 Aug 6;373(6):511-20. doi: 10.1056/NEJMoa1502000. Epub 2015 Jun 22.
Results Reference
derived
PubMed Identifier
26020620
Citation
Pollack CV Jr, Reilly PA, Bernstein R, Dubiel R, Eikelboom J, Glund S, Huisman MV, Hylek E, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Sellke F, Stangier J, Steiner T, Wang B, Weitz JI. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015 Jul;114(1):198-205. doi: 10.1160/TH15-03-0192. Epub 2015 May 28.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
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Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

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