Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
- Conditions
- Brain Injuries
- Interventions
- Drug: Lipid emulsion without progesterone
- Registration Number
- NCT01143064
- Lead Sponsor
- BHR Pharma, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1195
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Progesterone Progesterone - Lipid emulsion without progestrone Lipid emulsion without progesterone -
- Primary Outcome Measures
Name Time Method Glasgow Outcome Scale (GOS) 6 months The GOS 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
Name Time Method Mortality at Month 1 1 month post injury The mortality rate at one month will be compared between the two treatment groups.
Mortality at Month 6 6 months post injury The mortality rate at six months will be compared between the two treatment groups.
Glasgow Outcome Scale at 3 Months Month 3 The GOS assesses the mortality and disability in traumatic brain injury patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State, or Dead.
Glasgow Outcome Scale - Extended (GOS-E) 3 months and 6 months post injury 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 RecoveryShort Form (36) Health Survey (SF-36) 3 months and 6 months post injury The Short Form (36) Health Survey (SF-36) is a validated survey of patient health consisting of eight scaled scores which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, role physical, role emotional, role mental and mental health. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL) Admission through post-infusion Day 6 Cerebral Perfusion Pressure (CPP) levels are presented according to clinically significant cut-off values. CPP was calculated from intracranial pressures and mean arterial pressures measured from Day through Day 6 after initiation of study medication, if an ICP monitor was in place. Specific therapies received during Days 1-6 are summarized according to the Therapeutic Intensity Level (TIL) by treatment group, as maximum level of therapy administered to the subject.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (156)
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
LAC+USC Medical Center
🇺🇸Los Angeles, California, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Christiana Care Health System Hospital
🇺🇸Newark, Delaware, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
John H. Stroger Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Saint John's Hospital
🇺🇸Springfield, Illinois, United States
Wishard Health Services
🇺🇸Indianapolis, Indiana, United States
Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Mercy Medical Center
🇺🇸Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
LSU Health - Shreveport
🇺🇸Shreveport, Louisiana, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
St. Mary's of Michigan
🇺🇸Saginaw, Michigan, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Truman Medical Center Hospital Hill
🇺🇸Kansas City, Missouri, United States
Lester E. Cox Memorial Hospital
🇺🇸Springfield, Missouri, United States
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Albany Medical Center Hospital
🇺🇸Albany, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Wake Forest University-Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Summa Health System
🇺🇸Akron, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
St. Elizabeth Health Center
🇺🇸Youngstown, Ohio, United States
OU Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital & Health Center
🇺🇸Portland, Oregon, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of South Carolina School of Medicine
🇺🇸Columbia, South Carolina, United States
Johnson City Medical Center
🇺🇸Johnson City, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Marshall University Joan C. Edwards School of Medicine
🇺🇸Huntington, West Virginia, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Hospital Francisco Lopez Lima
🇦🇷General Roca, Rio Negro, Argentina
Hospital de Emergencias Clemente Alvarez (HECA)
🇦🇷Rosario, Santa Fe, Argentina
Hospital Nacional "Profesor Alejandro Posadas"
🇦🇷Buenos Aires, Argentina
Hospital Regional De Comodoro Rivadavia (HRCR)
🇦🇷Comodoro Rivadavia, Argentina
Hospital Central de Mendoza
🇦🇷Mendoza, Argentina
Hospital San Martin
🇦🇷Paraná, Argentina
Hospital Dr. José Maria Cullen
🇦🇷Santa Fé, Argentina
Medizinische Universität Graz
🇦🇹Graz, Austria
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria
Unfallkrankenhaus Salzburg
🇦🇹Salzburg, Austria
Landesklinikum Wiener Neustadt
🇦🇹Vienna, Austria
ULB Erasme
🇧🇪Brussels, Belgium
Ziekenhuis Oost-Limburg, Location Sint Jan
🇧🇪Genk, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
University Hospital of the Free University Brussels (UZ Brussel)
🇧🇪Jette, Belgium
University Hospital Gasthuisberg
🇧🇪Leuven, Belgium
Chengdu Military General Hospital
🇨🇳Chengdu, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, China
The 2nd Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, China
The Second Hospital of Shandong University
🇨🇳Jinan, China
Huashan Hospital of Fudan University
🇨🇳Shanghai, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
General Hospital of Tianjin Medical University
🇨🇳Tianjin, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, China
Fakultní nemocnice Brno Neurochirurgická klinika
🇨🇿Brno, Czechia
Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika
🇨🇿Brno, Czechia
Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení
🇨🇿Plzeň, Czechia
Fakultní nemocnice Kralovske Vinohrady
🇨🇿Praha, Czechia
Tampere University Hospital
🇫🇮Tampere, Finland
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Hôpital Pierre Wertheimer
🇫🇷Bron, France
Centre Hospitalier Universitaire de Grenoble- Hópital Michallon
🇫🇷La Tronche, France
CHRU de Lille- Hópital Roger Salengro
🇫🇷Lille, France
Centre Hospitalier Universitaire de Limoges
🇫🇷Limoges, France
Centre Hospitalier Universitaire Hôpital Nord
🇫🇷Marseille, France
Hópital Central - CHU de Nancy
🇫🇷Nancy, France
Groupe Hospitalier La Salpêtrière
🇫🇷Paris, France
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Klinikum der J.W. Goethe-Universität
🇩🇪Frankfurt, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Berufsgenossenschaftliche Kliniken
🇩🇪Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Krankenhaus Merheim
🇩🇪Köln, Germany
Universitätsklinikum Gießen und Marburg gGmbH
🇩🇪Marburg, Germany
Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Niels-Stensen-Kliniken
🇩🇪Osnabrück, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Honvédelmi Minisztérium Állami Egészségügyi Központ
🇭🇺Budapest, Hungary
Pécsi Tudományegyetem Általános Orvostudományi Kar
🇭🇺Pécs, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Hungary
Rambam Medical Center
🇮🇱Haifa, Israel
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach-Tikva, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Chaim Sheba Medical Center
🇮🇱Tel-Hashomer, Israel
Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
🇮🇹Milano, Italy
Fondazione San Raffaele del Monte Tabor
🇮🇹Milano, Italy
Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
Azienda Ospedaliero Universitaria Maggiore della Caritá
🇮🇹Novara, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Rome, Italy
Azienda Ospedaliero Universitaria Integrata di Verona
🇮🇹Verona, Italy
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Malaysia
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Spitalul Clinic Judetean de Urgenta Timisoara
🇷🇴Timisoara, Romania
State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development"
🇷🇺Kemerovo, Russian Federation
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"
🇷🇺Krasnoyarsk, Russian Federation
State Institution "Burdenko Neurosurgical Institute of RAMS"
🇷🇺Moscow, Russian Federation
State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin"
🇷🇺Murmansk, Russian Federation
Saint Petersburg Healthcare Institution "City Mariinsky Hospital"
🇷🇺St. Petersburg, Russian Federation
State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1"
🇷🇺Yekaterinburg, Russian Federation
National Neuroscience Institute
🇸🇬Singapore, Singapore
National University Hospital
🇸🇬Singapore, Singapore
Singapore General Hospital
🇸🇬Singapore, Singapore
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario Vall Hebrón
🇪🇸Barcelona, Spain
Hospital Universitario de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitari Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clínico Universitario De Valencia
🇪🇸Valencia, Spain
Hospital Universitari i Politecnic La Fé de Valencia
🇪🇸Valencia, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Chiang Mai University
🇹🇭Chiang Mai, Thailand
Faculty of Medicine, Prince of Songkla University
🇹🇭Hat yai, Thailand
Khon Kaen Hospital
🇹🇭Khon Kaen, Thailand
Royal Preston Hospital
🇬🇧Fulwood, Preston, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Leeds Teaching Hospitals NHS, Leeds General Infirmary
🇬🇧Leeds, United Kingdom
The Royal London Hospital
🇬🇧London, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Southampton University Hospital
🇬🇧Southampton, United Kingdom