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Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury (SyNAPSe)

Primary Purpose

Brain Injuries

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Progesterone
Lipid emulsion without progesterone
Sponsored by
BHR Pharma, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Brain Injury, Trauma

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients between the age of 16 and 70 years, inclusive
  2. Weight from 45 to 135 kg, inclusive
  3. Sustained a closed head trauma no more than 8 hours before start of study drug infusion
  4. TBI diagnosed by history and clinical examination
  5. Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive
  6. At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
  7. Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
  8. Indication for ICP monitoring

Exclusion Criteria:

  1. Life expectancy of less than 24 hours as determined by the Investigator
  2. Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) at the time of randomization
  3. Any spinal cord injury
  4. Pregnancy
  5. Penetrating head injury
  6. Bilaterally fixed dilated pupils at the time of randomization
  7. Coma suspected to be primarily due to other causes (e.g. alcohol)
  8. Pure epidural hematoma
  9. Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
  10. Severe cardiac or hemodynamic instability prior to randomization
  11. Known treatment with another investigational drug therapy or procedure within 30 days of injury
  12. A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
  13. Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
  14. Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)

Sites / Locations

  • University of South Alabama Medical Center
  • LAC+USC Medical Center
  • University of California San Diego Medical Center
  • Denver Health Medical Center
  • Christiana Care Health System Hospital
  • Delray Medical Center
  • Tallahassee Memorial Healthcare
  • Tampa General Hospital
  • Saint Alphonsus Regional Medical Center
  • John H. Stroger Jr. Hospital of Cook County
  • Advocate Lutheran General Hospital
  • Saint John's Hospital
  • Wishard Health Services
  • Methodist Hospital
  • Mercy Medical Center
  • University of Iowa Hospitals and Clinics
  • University of Kansas Medical Center
  • University of Louisville Hospital
  • LSU Health - Shreveport
  • Eastern Maine Medical Center
  • Maine Medical Center
  • Baystate Medical Center
  • University of Massachusetts Memorial Medical Center
  • Bronson Methodist Hospital
  • St. Mary's of Michigan
  • University of Missouri Health Care
  • Truman Medical Center Hospital Hill
  • Lester E. Cox Memorial Hospital
  • The Nebraska Medical Center
  • Robert Wood Johnson University Hospital
  • Albany Medical Center Hospital
  • Westchester Medical Center
  • Mission Hospital
  • Carolinas Medical Center
  • Duke University Medical Center
  • Wake Forest University-Baptist Medical Center
  • Summa Health System
  • MetroHealth Medical Center
  • Miami Valley Hospital
  • St. Elizabeth Health Center
  • OU Medical Center
  • Legacy Emanuel Hospital & Health Center
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • University of South Carolina School of Medicine
  • Johnson City Medical Center
  • Vanderbilt University Medical Center
  • Texas Tech University Health Sciences Center
  • University of Virginia Health System
  • Marshall University Joan C. Edwards School of Medicine
  • West Virginia University Hospital
  • University of Wisconsin Hospital and Clinics
  • Hospital Francisco Lopez Lima
  • Hospital de Emergencias Clemente Alvarez (HECA)
  • Hospital Central de Mendoza
  • Hospital San Martin
  • Hospital Nacional "Profesor Alejandro Posadas"
  • Hospital Regional De Comodoro Rivadavia (HRCR)
  • Hospital Dr. José Maria Cullen
  • Medizinische Universität Graz
  • Medizinische Universität Innsbruck
  • Unfallkrankenhaus Salzburg
  • Landesklinikum Wiener Neustadt
  • ULB Erasme
  • Ziekenhuis Oost-Limburg, Location Sint Jan
  • Universitair Ziekenhuis Gent
  • University Hospital of the Free University Brussels (UZ Brussel)
  • University Hospital Gasthuisberg
  • Chengdu Military General Hospital
  • The First Affiliated Hospital of Fujian Medical University
  • The 2nd Affiliated Hospital of Zhejiang University
  • The Second Hospital of Shandong University
  • Huashan Hospital of Fudan University
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • General Hospital of Tianjin Medical University
  • The Affiliated Hospital of Xuzhou Medical College
  • Fakultní nemocnice Brno Neurochirurgická klinika
  • Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika
  • Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení
  • Fakultní nemocnice Kralovske Vinohrady
  • Tampere University Hospital
  • Groupe Hospitalier Pellegrin
  • Hôpital Pierre Wertheimer
  • Centre Hospitalier Universitaire de Grenoble- Hópital Michallon
  • CHRU de Lille- Hópital Roger Salengro
  • Centre Hospitalier Universitaire de Limoges
  • Centre Hospitalier Universitaire Hôpital Nord
  • Hópital Central - CHU de Nancy
  • Groupe Hospitalier La Salpêtrière
  • Charité - Universitätsmedizin Berlin
  • Klinikum der J.W. Goethe-Universität
  • Universitätsmedizin Göttingen
  • Berufsgenossenschaftliche Kliniken
  • Universitätsklinikum Hamburg-Eppendorf
  • Universitätsklinikum Heidelberg
  • Krankenhaus Merheim
  • Universitätsklinikum Gießen und Marburg gGmbH
  • Klinikum Nürnberg
  • Niels-Stensen-Kliniken
  • Universitätsklinikum Ulm
  • Honvédelmi Minisztérium Állami Egészségügyi Központ
  • Pécsi Tudományegyetem Általános Orvostudományi Kar
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Rambam Medical Center
  • Hadassah Medical Organization
  • Rabin Medical Center
  • Tel Aviv Sourasky Medical Center
  • Chaim Sheba Medical Center
  • Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
  • Fondazione San Raffaele del Monte Tabor
  • Azienda Ospedaliera San Gerardo
  • Azienda Ospedaliero Universitaria Maggiore della Caritá
  • Azienda Ospedaliera San Camillo Forlanini
  • Azienda Ospedaliero Universitaria Integrata di Verona
  • Hospital Raja Permaisuri Bainun
  • Hospital Kuala Lumpur
  • University Malaya Medical Centre
  • Hospital Tengku Ampuan Afzan
  • Sarawak General Hospital
  • VU Medisch Centrum
  • Universitair Medisch Centrum Groningen
  • Spitalul Clinic Judetean de Urgenta Timisoara
  • State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development"
  • State Professional Institution of High Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development"
  • State Institution "Burdenko Neurosurgical Institute of RAMS"
  • State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin"
  • Saint Petersburg Healthcare Institution "City Mariinsky Hospital"
  • State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1"
  • National Neuroscience Institute
  • National University Hospital
  • Singapore General Hospital
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Parc Taulí
  • Hospital General Universitario de Alicante
  • Hospital Universitario de Bellvitge
  • Hospital Universitario Vall Hebrón
  • Hospital Universitario de Girona Dr. Josep Trueta
  • Hospital Universitario de Gran Canaria Dr. Negrín
  • Hospital Universitario 12 de Octubre
  • Hospital Universitari Son Espases
  • Hospital Universitario Virgen del Rocio
  • Hospital Clínico Universitario De Valencia
  • Hospital Universitari i Politecnic La Fé de Valencia
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Chiang Mai University
  • Faculty of Medicine, Prince of Songkla University
  • Khon Kaen Hospital
  • Royal Preston Hospital
  • Queen Elizabeth Hospital
  • University Hospital Coventry
  • Leeds Teaching Hospitals NHS, Leeds General Infirmary
  • The Royal London Hospital
  • The James Cook University Hospital
  • Southampton University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Progesterone

Lipid emulsion without progestrone

Arm Description

Outcomes

Primary Outcome Measures

Glasgow Outcome Scale (GOS)
The GOS (Jennett and Bond, 1975) assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.

Secondary Outcome Measures

Mortality
The mortality rate at one and six months will be compared between the two treatment groups.
Glasgow Outcome Scale
Glasgow Outcome Scale - Extended (GOS-E)
The GOS-E assessment of mortality and disability in TBI patients extends the original five GOS categories of functional outcome to eight categories: Dead Vegetative State Lower Severe Disability Upper Severe Disability Lower Moderate Disability Upper Moderate Disability Lower Good Recovery Upper Good Recovery
Short Form (36) Health Survey (SF-36)
The SF-36 is a validated survey of patient health consisting of eight scaled scores. The eight sections are: vitality physical functioning bodily pain general health perceptions role physical role emotional role mental mental health The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health.
Effect of progesterone on Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and Therapeutic Intensity Level (TIL)
Effect of progesterone on the progression of intracranial pathology

Full Information

First Posted
June 10, 2010
Last Updated
June 11, 2014
Sponsor
BHR Pharma, LLC
Collaborators
PRA Health Sciences, Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT01143064
Brief Title
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
Acronym
SyNAPSe
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BHR Pharma, LLC
Collaborators
PRA Health Sciences, Syneos Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
Brain Injury, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone
Arm Type
Active Comparator
Arm Title
Lipid emulsion without progestrone
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
BHR-100
Intervention Description
Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Intervention Type
Drug
Intervention Name(s)
Lipid emulsion without progesterone
Intervention Description
Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Primary Outcome Measure Information:
Title
Glasgow Outcome Scale (GOS)
Description
The GOS (Jennett and Bond, 1975) assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mortality
Description
The mortality rate at one and six months will be compared between the two treatment groups.
Time Frame
1 month and 6 months post injury
Title
Glasgow Outcome Scale
Time Frame
Month 3
Title
Glasgow Outcome Scale - Extended (GOS-E)
Description
The GOS-E assessment of mortality and disability in TBI patients extends the original five GOS categories of functional outcome to eight categories: Dead Vegetative State Lower Severe Disability Upper Severe Disability Lower Moderate Disability Upper Moderate Disability Lower Good Recovery Upper Good Recovery
Time Frame
3 months and 6 months post injury
Title
Short Form (36) Health Survey (SF-36)
Description
The SF-36 is a validated survey of patient health consisting of eight scaled scores. The eight sections are: vitality physical functioning bodily pain general health perceptions role physical role emotional role mental mental health The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health.
Time Frame
3 months and 6 months post injury
Title
Effect of progesterone on Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and Therapeutic Intensity Level (TIL)
Time Frame
Admission through post-infusion Day 6
Title
Effect of progesterone on the progression of intracranial pathology
Time Frame
Admission and Day 6 computed tomography (CT) scans

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients between the age of 16 and 70 years, inclusive Weight from 45 to 135 kg, inclusive Sustained a closed head trauma no more than 8 hours before start of study drug infusion TBI diagnosed by history and clinical examination Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive) Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification) Indication for ICP monitoring Exclusion Criteria: Life expectancy of less than 24 hours as determined by the Investigator Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) at the time of randomization Any spinal cord injury Pregnancy Penetrating head injury Bilaterally fixed dilated pupils at the time of randomization Coma suspected to be primarily due to other causes (e.g. alcohol) Pure epidural hematoma Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome Severe cardiac or hemodynamic instability prior to randomization Known treatment with another investigational drug therapy or procedure within 30 days of injury A history of allergic reaction to progesterone and related drugs or any of the components of the infusion Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neta R. Nelson, MPH
Organizational Affiliation
BHR Pharma, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Christiana Care Health System Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Delray Medical Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Tallahassee Memorial Healthcare
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
John H. Stroger Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Saint John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
Wishard Health Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46206
Country
United States
Facility Name
Mercy Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LSU Health - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
St. Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Truman Medical Center Hospital Hill
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Lester E. Cox Memorial Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Albany Medical Center Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University-Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
St. Elizabeth Health Center
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
OU Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Legacy Emanuel Hospital & Health Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
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
University of South Carolina School of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Johnson City Medical Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Marshall University Joan C. Edwards School of Medicine
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Hospital Francisco Lopez Lima
City
General Roca
State/Province
Rio Negro
Country
Argentina
Facility Name
Hospital de Emergencias Clemente Alvarez (HECA)
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
Hospital Central de Mendoza
City
Mendoza
Country
Argentina
Facility Name
Hospital San Martin
City
Paraná
Country
Argentina
Facility Name
Hospital Nacional "Profesor Alejandro Posadas"
City
Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Regional De Comodoro Rivadavia (HRCR)
City
Provincia de Chubut
Country
Argentina
Facility Name
Hospital Dr. José Maria Cullen
City
Santa Fé
Country
Argentina
Facility Name
Medizinische Universität Graz
City
Graz
Country
Austria
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Unfallkrankenhaus Salzburg
City
Salzburg
Country
Austria
Facility Name
Landesklinikum Wiener Neustadt
City
Vienna
Country
Austria
Facility Name
ULB Erasme
City
Brussels
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg, Location Sint Jan
City
Genk
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Facility Name
University Hospital of the Free University Brussels (UZ Brussel)
City
Jette
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Chengdu Military General Hospital
City
Chengdu
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
Country
China
Facility Name
The 2nd Affiliated Hospital of Zhejiang University
City
Hangzhou
Country
China
Facility Name
The Second Hospital of Shandong University
City
Jinan
Country
China
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
Country
China
Facility Name
Fakultní nemocnice Brno Neurochirurgická klinika
City
Brno
Country
Czech Republic
Facility Name
Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika
City
Brno
Country
Czech Republic
Facility Name
Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení
City
Plzeň
Country
Czech Republic
Facility Name
Fakultní nemocnice Kralovske Vinohrady
City
Praha
Country
Czech Republic
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Groupe Hospitalier Pellegrin
City
Bordeaux
Country
France
Facility Name
Hôpital Pierre Wertheimer
City
Bron
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble- Hópital Michallon
City
La Tronche
Country
France
Facility Name
CHRU de Lille- Hópital Roger Salengro
City
Lille
Country
France
Facility Name
Centre Hospitalier Universitaire de Limoges
City
Limoges
Country
France
Facility Name
Centre Hospitalier Universitaire Hôpital Nord
City
Marseille
Country
France
Facility Name
Hópital Central - CHU de Nancy
City
Nancy
Country
France
Facility Name
Groupe Hospitalier La Salpêtrière
City
Paris
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Klinikum der J.W. Goethe-Universität
City
Frankfurt
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
Country
Germany
Facility Name
Berufsgenossenschaftliche Kliniken
City
Halle
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Krankenhaus Merheim
City
Köln
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg gGmbH
City
Marburg
Country
Germany
Facility Name
Klinikum Nürnberg
City
Nürnberg
Country
Germany
Facility Name
Niels-Stensen-Kliniken
City
Osnabrück
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Honvédelmi Minisztérium Állami Egészségügyi Központ
City
Budapest
Country
Hungary
Facility Name
Pécsi Tudományegyetem Általános Orvostudományi Kar
City
Pécs
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petach-Tikva
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel-Hashomer
Country
Israel
Facility Name
Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
City
Milano
Country
Italy
Facility Name
Fondazione San Raffaele del Monte Tabor
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Maggiore della Caritá
City
Novara
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Integrata di Verona
City
Verona
Country
Italy
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh, Perak
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan, Pahang
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching, Sarawak
Country
Malaysia
Facility Name
VU Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
Country
Netherlands
Facility Name
Spitalul Clinic Judetean de Urgenta Timisoara
City
Timisoara
Country
Romania
Facility Name
State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development"
City
Kemerovo
Country
Russian Federation
Facility Name
State Professional Institution of High Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development"
City
Krasnoyarsk
Country
Russian Federation
Facility Name
State Institution "Burdenko Neurosurgical Institute of RAMS"
City
Moscow
Country
Russian Federation
Facility Name
State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin"
City
Murmansk
Country
Russian Federation
Facility Name
Saint Petersburg Healthcare Institution "City Mariinsky Hospital"
City
St. Petersburg
Country
Russian Federation
Facility Name
State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1"
City
Yekaterinburg
Country
Russian Federation
Facility Name
National Neuroscience Institute
City
Singapore
Country
Singapore
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Parc Taulí
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Vall Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Girona Dr. Josep Trueta
City
Girona
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrín
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Clínico Universitario De Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fé de Valencia
City
Valencia
Country
Spain
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Chiang Mai University
City
Chiang Mai
Country
Thailand
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Hat yai
Country
Thailand
Facility Name
Khon Kaen Hospital
City
Khon Kaen
Country
Thailand
Facility Name
Royal Preston Hospital
City
Fulwood
State/Province
Preston
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS, Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
Country
United Kingdom
Facility Name
The James Cook University Hospital
City
Middlesbrough
Country
United Kingdom
Facility Name
Southampton University Hospital
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17011666
Citation
Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS, Lowery DW, Patel MM, Denson DD, Gordon AB, Wald MM, Gupta S, Hoffman SW, Stein DG. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med. 2007 Apr;49(4):391-402, 402.e1-2. doi: 10.1016/j.annemergmed.2006.07.932. Epub 2006 Sep 29.
Results Reference
background
PubMed Identifier
18447940
Citation
Xiao G, Wei J, Yan W, Wang W, Lu Z. Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial. Crit Care. 2008;12(2):R61. doi: 10.1186/cc6887. Epub 2008 Apr 30.
Results Reference
background
PubMed Identifier
25493978
Citation
Skolnick BE, Maas AI, Narayan RK, van der Hoop RG, MacAllister T, Ward JD, Nelson NR, Stocchetti N; SYNAPSE Trial Investigators. A clinical trial of progesterone for severe traumatic brain injury. N Engl J Med. 2014 Dec 25;371(26):2467-76. doi: 10.1056/NEJMoa1411090. Epub 2014 Dec 10.
Results Reference
derived
Links:
URL
http://www.synapse-trial.com
Description
Trial website

Learn more about this trial

Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

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