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Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

Primary Purpose

Severe Sepsis, Coagulopathy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ART-123
Placebo
Sponsored by
Asahi Kasei Pharma America Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring sepsis

Eligibility Criteria

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

Inclusion Criteria:

  • Subject must be receiving treatment in an ICU, or in an acute care setting (e.g., ER, RR)
  • Clinical objective evidence of bacterial infection and a known site of infection.
  • Cardiovascular dysfunction or Respiratory Failure due to sepsis.
  • Coagulopathy characterized by an INR >1.40 without other known causes.

Exclusion Criteria:

  • Subject or Authorized Representative is unable to provide informed consent.
  • Subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study.
  • Subject is of childbearing potential and does not have a negative pregnancy test.
  • Subject is < 18 years of age.
  • Subject has a known allergy to ART-123 or any components of the drug product.
  • Subject is unwilling to allow transfusion of blood or blood products.
  • Subject has an advance directive to withhold life-sustaining treatment.
  • Subject has had previous treatment with ART-123.
  • Body weight ≥ 175 kg.
  • Platelets < 30,000/ mm3 for any reason, PT prolongation or thrombocytopenia that is not due to sepsis.
  • Any surgery that is potentially hemorrhagic (e.g. intra-thoracic, intra-abdominal or non-traumatic orthopedic surgery of the femur or pelvis) that is completed within 12 hours prior to first dose of study drug, or ongoing impairment of hemostasis as a result of one of these procedures
  • History of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to consent.
  • Cerebral Vascular Accident (CVA) within 3 months prior to consent.
  • Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system.
  • History of congenital bleeding diathesesor anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia).
  • Significant gastrointestinal bleeding within 6 weeks prior to consent.
  • Subject is diagnosed with a known medical condition associated with a hypercoagulable state.
  • Child-Pugh score of 10-15 (Class C)
  • Portosystemic hypertension or known history of bleeding esophageal varices.
  • History of solid organ, allogeneic bone marrow, or stem cell transplantation within the 6 months prior to consent.
  • Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture or gram stain consistent with bacterial infection.
  • Subjects with renal dysfunction defined as (a) Chronic renal failure requiring renal replacement therapy (RRT), or (b) Acute renal failure with onset of oliguria (urine output < 0.3 ml/kg/hr) > 48 hours prior to first dose of study drug whether receiving RRT or not
  • Use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 72 hours prior to first does of study drug.
  • Life expectancy < 90 days.
  • Current use of any chemotherapy agent likely to cause myeloablation (severe or complete depletion of bone marrow).
  • Participation in another research study involving an investigational agent within 30 days prior to consent or projected study participation during the 28 days post study randomization.
  • Confirmed or suspected endocarditis

Sites / Locations

  • Detroit Receiving Hospital
  • Harper Hospital - Wayne State University School of Medicine
  • Sinai-Grace Hospital
  • Washington University in St. Louis
  • Memorial Sloan Kettering Cancer Center
  • 2 of 2
  • Hospital Italiano de Cordoba
  • Prince of Wales Hospital
  • Royal Brisbane and Women's Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Bendigo Hospital
  • Monash Medical Centre
  • Dandenong Hospital Monash Health
  • Western Hospital
  • Austin Health
  • Sunshine Hospital
  • UZ Antwerpen
  • Cliniques Du Sud-Luxerbourg (CSL), Hospital Saint Joseph
  • CHU Brugmann
  • Hopital Erasme
  • Hopitaux Iris Sud
  • UCL St. Luc
  • UZ Brussel
  • Centre Hospitalier de Dinant
  • UZ Gent
  • Clinique Saint-Pierre
  • UCL Mont-Godinne
  • Santa Casa de Misericordia de Belo Horizonte
  • Fundaçao Faculdade Regional de Medicina Sao Jose do Rio Preto
  • Hospital Pompéia
  • Anesthesiology and Intensive Care Clinic, University Multiprofile Hospital For Active Treatment "Sveti Georgi", Plovdiv
  • Department of Anesthesiology and Intensive Care Multiprofile Hospital For Active Treatment "Tokuda Hospital Sofia", Sofia
  • 2 of 2
  • 2 of 2
  • 1 of 2
  • 1 of 2
  • 2 of 2
  • Clinical Hospital Center Zagreb, Medical ICU
  • Clinical Hospital Dubrava, Department of Anesthesiology and resuscitation
  • University Hospital Center Zagreb, Department of Anesthesiology, Reanimatology and Intensive Care Medicine
  • University Hospital Brno, Department of Infectious Diseases
  • University Hospital Hradec Kralove, Department of Anaesthesiology, Resuscitation and Intensive Care
  • University Hospital Kralovske Vinohrady, Department of Anesthesiology and Resuscitation
  • General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine
  • Masaryk´s Hospital Ustni nad Labem, o.z., Department of Infectious Diseases
  • Helsingin Yliopistollinen Keskussairaala (HYKS) (Helsinki University Central Hospital (HUCH))
  • Keski-Suomen Keskussairaala (Central Finland Central Hospital)
  • Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital)
  • Tampereen Yliopistollinen Sairaala (Tampere University Hospital) (TAYS) - Keskussairaala (Central Hospital)
  • Archet 1 University Hospital of Nice
  • Service de reanimation médicale. CHU Hotel Dieu
  • CHU D'Anger
  • CHU de Dijon, Hopital Bocage Central
  • CH-Hôpital Albert Michallon
  • Centre Hospitalier Départemental de Vendée-Les Oudairies
  • CHRU Lille-Pole Reanimation
  • CHU Limoges
  • Centre Hospitalier Universitaire Nîmes
  • La Pitié Salpétrière, Paris
  • Hôpital COCHIN
  • University Hospital of Bordeaux
  • CH Lyon Sud
  • Nouvel hospital civil
  • Hôpital Sainte Musse
  • CHU Tours, Hopital Bretonneau
  • Universitätsklinikum der RWTH Aachen
  • Helios Klinikum Erfurt
  • Klinikum der Johann-Wolfgang Goethe-Universität
  • Szent Imre Hospital, Anesthesiology and Intensive Care Unit
  • Maulana Azad Medical College and Associated L N Hospital
  • Shalby Hospital
  • Shalby
  • Artemis Hospital
  • Ruby Hall Clinic
  • Noble Hospital
  • King Edward Memorial Hospital & Research Centre
  • Hi-tech Medical College & Hospital
  • Bharati Vidyapeeth Deemed University Medical College Bharti Hospital and Research Centre
  • St. Theresa Hospital
  • Mazumdar Shaw Medical Centre (Unit of Narayana Health)
  • KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
  • JSS Hospital
  • Care Hospital
  • Noble Hospital
  • Barzilai Medical Center
  • Rambam Medical Center
  • The Lady Davis Carmel Medical Center
  • Shaare Zedek Medical Center
  • Rabin Medical Center
  • Kaplan Medical Center
  • Korea University Anam Hospital
  • Asan Medical Center
  • Samsung Medical Center [Pulmonology]
  • Seoul National University Hospital
  • Jeroen Bosch Ziekenhuis
  • VUMC
  • Ziekenhuis Gelderse Vallei
  • Medisch Spectrum Twente
  • University Medical Center Groningen
  • Medisch Centrum Leeuwarden
  • UMC St. Radboud
  • Ikazia Ziekenhuis
  • Auckland District Health Board
  • Christchurch Hospital
  • Hawkes Bay Regional Hospital Intensive Care Unit Omahu Road
  • Wellington District Health Board
  • Hospital Nacional Almenara Yrigoyen - EsSALUD
  • Hospital Nacional FAP
  • Arkhangelsk Regional Clinical Hospital
  • Volosevich City Clinical Hospital #1
  • City Clinical Hospital #3 n.a. M.A. Pogorbunskiy
  • Kuban State Medical University (Site Facility: Krasnodar Regional Clinical Hospital #2)
  • Krasnoyarsk Regional Clinocal Hospital
  • Vishnevsky Institute of Surgery
  • St George City Hospital
  • City Hospital #40
  • City Hospital #4
  • Aleksandrovskaya City Hospital
  • Mariinskaya City Hospital
  • Mechnikov North-Western State Medical University n.a. I.I. Mechnikov
  • Clinic for Infectious Diseases, Clinical Center Nis
  • Complexo Hospitalario Universitario A Coruña
  • Hospital Universitario Mutua Terrassa Intensive Care
  • Servicio de Medicina Intensiva Hospital Universitario Valle de Hebron
  • Hospital Clínico San Carlos
  • Hospital de Sabadell
  • Hospital Universitari de Tarragona Joan XXIII
  • Chi Mei Medical Center Yong Kang
  • Taichung Veterans General Hospital [Pulmonology]
  • National Taiwan University Hospital
  • Birmingham Heartlands Hospital
  • Hull Royal Infirmary
  • Royal Liverpool University Hospital
  • Manchester Royal Infirmary
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ART-123

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With 28-Day All-cause Mortality
28-Day All-cause Mortality
Number of Participants With On-Treatment Serious Major Bleeding Events
On-treatment Serious Major Bleeding Events collected as Serious Adverse Events and defined as: any intracranial hemorrhage, any life-threatening bleeding, any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days. (Investigator assessment for seriousness criteria.)

Secondary Outcome Measures

Follow up All-cause Mortality at 3 Months
Follow up all-cause mortality at 3 months
Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction
Resolution of organ dysfunction as measured through day 28 by shock free, ventilator free, dialysis free plus alive days.
Number of Participants With Anti-drug Antibodies
Presence of Anti-drug antibodies up to 18 months

Full Information

First Posted
May 11, 2012
Last Updated
April 18, 2020
Sponsor
Asahi Kasei Pharma America Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01598831
Brief Title
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 29, 2012 (Actual)
Primary Completion Date
April 5, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma America Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
Detailed Description
Study is to evaluate if ART-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Coagulopathy
Keywords
sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
816 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ART-123
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ART-123
Other Intervention Name(s)
human recombinant thrombomodulin, thrombomodulin alfa
Intervention Description
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.
Primary Outcome Measure Information:
Title
Number of Participants With 28-Day All-cause Mortality
Description
28-Day All-cause Mortality
Time Frame
28 days
Title
Number of Participants With On-Treatment Serious Major Bleeding Events
Description
On-treatment Serious Major Bleeding Events collected as Serious Adverse Events and defined as: any intracranial hemorrhage, any life-threatening bleeding, any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days. (Investigator assessment for seriousness criteria.)
Time Frame
Through Study Day 28
Secondary Outcome Measure Information:
Title
Follow up All-cause Mortality at 3 Months
Description
Follow up all-cause mortality at 3 months
Time Frame
3 months
Title
Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction
Description
Resolution of organ dysfunction as measured through day 28 by shock free, ventilator free, dialysis free plus alive days.
Time Frame
28 days
Title
Number of Participants With Anti-drug Antibodies
Description
Presence of Anti-drug antibodies up to 18 months
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be receiving treatment in an ICU, or in an acute care setting (e.g., ER, RR) Clinical objective evidence of bacterial infection and a known site of infection. Cardiovascular dysfunction or Respiratory Failure due to sepsis. Coagulopathy characterized by an INR >1.40 without other known causes. Exclusion Criteria: Subject or Authorized Representative is unable to provide informed consent. Subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study. Subject is of childbearing potential and does not have a negative pregnancy test. Subject is < 18 years of age. Subject has a known allergy to ART-123 or any components of the drug product. Subject is unwilling to allow transfusion of blood or blood products. Subject has an advance directive to withhold life-sustaining treatment. Subject has had previous treatment with ART-123. Body weight ≥ 175 kg. Platelets < 30,000/ mm3 for any reason, PT prolongation or thrombocytopenia that is not due to sepsis. Any surgery that is potentially hemorrhagic (e.g. intra-thoracic, intra-abdominal or non-traumatic orthopedic surgery of the femur or pelvis) that is completed within 12 hours prior to first dose of study drug, or ongoing impairment of hemostasis as a result of one of these procedures History of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to consent. Cerebral Vascular Accident (CVA) within 3 months prior to consent. Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system. History of congenital bleeding diathesesor anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia). Significant gastrointestinal bleeding within 6 weeks prior to consent. Subject is diagnosed with a known medical condition associated with a hypercoagulable state. Child-Pugh score of 10-15 (Class C) Portosystemic hypertension or known history of bleeding esophageal varices. History of solid organ, allogeneic bone marrow, or stem cell transplantation within the 6 months prior to consent. Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture or gram stain consistent with bacterial infection. Subjects with renal dysfunction defined as (a) Chronic renal failure requiring renal replacement therapy (RRT), or (b) Acute renal failure with onset of oliguria (urine output < 0.3 ml/kg/hr) > 48 hours prior to first dose of study drug whether receiving RRT or not Use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 72 hours prior to first does of study drug. Life expectancy < 90 days. Current use of any chemotherapy agent likely to cause myeloablation (severe or complete depletion of bone marrow). Participation in another research study involving an investigational agent within 30 days prior to consent or projected study participation during the 28 days post study randomization. Confirmed or suspected endocarditis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Fineberg, M.D.
Organizational Affiliation
Asahi Kasei Pharma America Corporation
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Harper Hospital - Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Sinai-Grace Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
2 of 2
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Hospital Italiano de Cordoba
City
Cordoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Bendigo Hospital
City
Bendigo
State/Province
Victoria
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Dandenong Hospital Monash Health
City
Dandenong
State/Province
Victoria
ZIP/Postal Code
3175
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Sunshine Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
UZ Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
Cliniques Du Sud-Luxerbourg (CSL), Hospital Saint Joseph
City
Arlon
Country
Belgium
Facility Name
CHU Brugmann
City
Brussels
Country
Belgium
Facility Name
Hopital Erasme
City
Brussels
Country
Belgium
Facility Name
Hopitaux Iris Sud
City
Brussels
Country
Belgium
Facility Name
UCL St. Luc
City
Brussels
Country
Belgium
Facility Name
UZ Brussel
City
Brussels
Country
Belgium
Facility Name
Centre Hospitalier de Dinant
City
Dinant
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Clinique Saint-Pierre
City
Ottignies
Country
Belgium
Facility Name
UCL Mont-Godinne
City
Yvoir
Country
Belgium
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Fundaçao Faculdade Regional de Medicina Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
Country
Brazil
Facility Name
Hospital Pompéia
City
Brasil
ZIP/Postal Code
95010-005
Country
Brazil
Facility Name
Anesthesiology and Intensive Care Clinic, University Multiprofile Hospital For Active Treatment "Sveti Georgi", Plovdiv
City
Plovdiv
Country
Bulgaria
Facility Name
Department of Anesthesiology and Intensive Care Multiprofile Hospital For Active Treatment "Tokuda Hospital Sofia", Sofia
City
Sofia
Country
Bulgaria
Facility Name
2 of 2
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1PA
Country
Canada
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
2 of 2
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
1 of 2
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R-1J8
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R1J8
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada
Facility Name
1 of 2
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIH 8L6
Country
Canada
Facility Name
2 of 2
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIH 8L6
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinical Hospital Center Zagreb, Medical ICU
City
Zagreb
Country
Croatia
Facility Name
Clinical Hospital Dubrava, Department of Anesthesiology and resuscitation
City
Zagreb
Country
Croatia
Facility Name
University Hospital Center Zagreb, Department of Anesthesiology, Reanimatology and Intensive Care Medicine
City
Zagreb
Country
Croatia
Facility Name
University Hospital Brno, Department of Infectious Diseases
City
Brno
Country
Czechia
Facility Name
University Hospital Hradec Kralove, Department of Anaesthesiology, Resuscitation and Intensive Care
City
Hradec Kralove
Country
Czechia
Facility Name
University Hospital Kralovske Vinohrady, Department of Anesthesiology and Resuscitation
City
Prague 10
Country
Czechia
Facility Name
General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine
City
Prague 2
Country
Czechia
Facility Name
Masaryk´s Hospital Ustni nad Labem, o.z., Department of Infectious Diseases
City
Usti nad Labem
Country
Czechia
Facility Name
Helsingin Yliopistollinen Keskussairaala (HYKS) (Helsinki University Central Hospital (HUCH))
City
Helsinki
Country
Finland
Facility Name
Keski-Suomen Keskussairaala (Central Finland Central Hospital)
City
Jyväskylä
Country
Finland
Facility Name
Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital)
City
Kuopio
Country
Finland
Facility Name
Tampereen Yliopistollinen Sairaala (Tampere University Hospital) (TAYS) - Keskussairaala (Central Hospital)
City
Tampere
Country
Finland
Facility Name
Archet 1 University Hospital of Nice
City
Nice
State/Province
Cedex 3
ZIP/Postal Code
23079
Country
France
Facility Name
Service de reanimation médicale. CHU Hotel Dieu
City
Nantes
State/Province
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
CHU D'Anger
City
Angers Cedex 9
Country
France
Facility Name
CHU de Dijon, Hopital Bocage Central
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CH-Hôpital Albert Michallon
City
Grenoble cedex 09
Country
France
Facility Name
Centre Hospitalier Départemental de Vendée-Les Oudairies
City
La Roche-Sur-Yon cedex 9
Country
France
Facility Name
CHRU Lille-Pole Reanimation
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Limoges
City
Limoges cedex
Country
France
Facility Name
Centre Hospitalier Universitaire Nîmes
City
Nîmes Cedex 9
Country
France
Facility Name
La Pitié Salpétrière, Paris
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital COCHIN
City
Paris
Country
France
Facility Name
University Hospital of Bordeaux
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
CH Lyon Sud
City
Pierre-Bénite cedex
Country
France
Facility Name
Nouvel hospital civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpital Sainte Musse
City
Toulon
Country
France
Facility Name
CHU Tours, Hopital Bretonneau
City
Tours
Country
France
Facility Name
Universitätsklinikum der RWTH Aachen
City
Aachen
ZIP/Postal Code
54074
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang Goethe-Universität
City
Frankfurt am Main
Country
Germany
Facility Name
Szent Imre Hospital, Anesthesiology and Intensive Care Unit
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Maulana Azad Medical College and Associated L N Hospital
City
New Delhi
State/Province
Delhi
Country
India
Facility Name
Shalby Hospital
City
Ahmedabad,
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Shalby
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Artemis Hospital
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Noble Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411013
Country
India
Facility Name
King Edward Memorial Hospital & Research Centre
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Hi-tech Medical College & Hospital
City
Bhubaneswar
State/Province
Odisha
Country
India
Facility Name
Bharati Vidyapeeth Deemed University Medical College Bharti Hospital and Research Centre
City
Pune
State/Province
Pune, Maharashtra
ZIP/Postal Code
411043
Country
India
Facility Name
St. Theresa Hospital
City
Hyderabad
State/Province
Telangana State
ZIP/Postal Code
500018
Country
India
Facility Name
Mazumdar Shaw Medical Centre (Unit of Narayana Health)
City
Bangalore
ZIP/Postal Code
560099
Country
India
Facility Name
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
City
Belgaum
ZIP/Postal Code
590010
Country
India
Facility Name
JSS Hospital
City
Mysore
ZIP/Postal Code
570004
Country
India
Facility Name
Care Hospital
City
Nagpur
ZIP/Postal Code
440010
Country
India
Facility Name
Noble Hospital
City
Pune
ZIP/Postal Code
411013
Country
India
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
Country
Israel
Facility Name
Korea University Anam Hospital
City
Seongdu
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center [Pulmonology]
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
Country
Netherlands
Facility Name
VUMC
City
Amsterdam
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Auckland District Health Board
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Hawkes Bay Regional Hospital Intensive Care Unit Omahu Road
City
Hastings
Country
New Zealand
Facility Name
Wellington District Health Board
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Hospital Nacional Almenara Yrigoyen - EsSALUD
City
Lima
State/Province
Lima Province
Country
Peru
Facility Name
Hospital Nacional FAP
City
Lima
State/Province
Lima Province
Country
Peru
Facility Name
Arkhangelsk Regional Clinical Hospital
City
Arkhangelsk
Country
Russian Federation
Facility Name
Volosevich City Clinical Hospital #1
City
Arkhangelsk
Country
Russian Federation
Facility Name
City Clinical Hospital #3 n.a. M.A. Pogorbunskiy
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Kuban State Medical University (Site Facility: Krasnodar Regional Clinical Hospital #2)
City
Krasnodar
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinocal Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Vishnevsky Institute of Surgery
City
Moscow
Country
Russian Federation
Facility Name
St George City Hospital
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
City Hospital #40
City
Saint Petersburg
Country
Russian Federation
Facility Name
City Hospital #4
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Aleksandrovskaya City Hospital
City
St. Petersburg
Country
Russian Federation
Facility Name
Mariinskaya City Hospital
City
St. Petersburg
Country
Russian Federation
Facility Name
Mechnikov North-Western State Medical University n.a. I.I. Mechnikov
City
St. Petersburg
Country
Russian Federation
Facility Name
Clinic for Infectious Diseases, Clinical Center Nis
City
Nis
Country
Serbia
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruña
Country
Spain
Facility Name
Hospital Universitario Mutua Terrassa Intensive Care
City
Barcelona
Country
Spain
Facility Name
Servicio de Medicina Intensiva Hospital Universitario Valle de Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital de Sabadell
City
Sabadell
Country
Spain
Facility Name
Hospital Universitari de Tarragona Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Chi Mei Medical Center Yong Kang
City
Yongkang
State/Province
Tainan
Country
Taiwan
Facility Name
Taichung Veterans General Hospital [Pulmonology]
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32697484
Citation
Levi M, Vincent JL, Tanaka K, Radford AH, Kayanoki T, Fineberg DA, Hoppensteadt D, Fareed J. Effect of a Recombinant Human Soluble Thrombomodulin on Baseline Coagulation Biomarker Levels and Mortality Outcome in Patients With Sepsis-Associated Coagulopathy. Crit Care Med. 2020 Aug;48(8):1140-1147. doi: 10.1097/CCM.0000000000004426.
Results Reference
derived
PubMed Identifier
31104069
Citation
Vincent JL, Francois B, Zabolotskikh I, Daga MK, Lascarrou JB, Kirov MY, Pettila V, Wittebole X, Meziani F, Mercier E, Lobo SM, Barie PS, Crowther M, Esmon CT, Fareed J, Gando S, Gorelick KJ, Levi M, Mira JP, Opal SM, Parrillo J, Russell JA, Saito H, Tsuruta K, Sakai T, Fineberg D; SCARLET Trial Group. Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1993-2002. doi: 10.1001/jama.2019.5358.
Results Reference
derived
Links:
URL
http://internationalsepsisforum.com/
Description
Information on sepsis and treatment

Learn more about this trial

Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

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