Clinical trials: Major Bleed
Congenital Bleeding Disorder, Haemophilia A
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who…
- Trial name
- pathfinder™5 (NCT01731600)
- Testing
- turoctocog alfa pegol
- Where
- 51 sites in United States, Brazil and 14 more
- Volunteers
- 68 people
- Sponsor
- Novo Nordisk A/S
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Brain Injuries
Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury
The study's objective is to evaluate the effectiveness and safety of tranexamic acid for adult patients with moderate to severe TBI.With the research question as "Does TXA reduce the incidence of progressive intracranial…
- Trial name
- NCT00755209
- Testing
- tranexamic acid
- Where
- Thailand
- Volunteers
- 238 people
- Sponsor
- Khon Kaen University
Hemophilia A
Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels.
- Trial name
- NCT01775618
- Testing
- BAY94-9027
- Where
- 37 sites in United States, Argentina and 15 more
- Volunteers
- 73 people
- Sponsor
- Bayer
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.
- Trial name
- pathfinder™6 (NCT02137850)
- Testing
- turoctocog alfa pegol
- Where
- 96 sites in United States, Algeria and 21 more
- Volunteers
- 124 people
- Sponsor
- Novo Nordisk A/S
Consciousness Disorders, Persistent Vegetative State
Multimodal Assessment and Prognosis in Disorders of Consciousness After Severe Brain Injury (CyDoC-MAP)
After a severe brain injury some patients survive but cannot communicate, and deciding early which of them are likely to recover consciousness remains one of the hardest problems in neurocritical care.
- Conditions
- Consciousness Disorders, Persistent Vegetative State, Unresponsive Wakefulness Syndrome, Minimally Conscious State
- Trial name
- CyDoC-MAP (NCT07736820)
- Where
- Cyprus
- Volunteers
- 40 people
- Sponsor
- Nicosia General Hospital
Major Depressive Disorder
A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression
This study is a retrospective database study in Japan to evaluate the relative risk of serious intracranial hemorrhage requiring hospitalization between Vortioxetine tablet treatment and selective serotonin reuptake inhibitor…
- Trial name
- NCT05932407
- Testing
- Vortioxetine Tablet, SSRI
- Where
- Japan
- Volunteers
- 147,777 people
- Sponsor
- Takeda
Hemophilia A
UPLC-MS/MS Monitoring of Emicizumab Therapy
Emicizumab is a monoclonal bispecific antibody with a terminal half-life of 28 days which is now licensed in the treatment of severe haemophilia A with or without inhibitors.
- Trial name
- EMICARE (NCT04472169)
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Lille
Head Trauma, Crushing Skull Injury
Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the portable near-infrared-based device (portable NIR-based device), the InfraScanner 2500™, to detect…
- Conditions
- Head Trauma, Crushing Skull Injury, Head Injury, Head Injuries, Multiple
- Trial name
- NCT06491173
- Testing
- InfraScanner 2500™
- Where
- 2 sites in Uganda
- Volunteers
- 180 people
- Sponsor
- Duke University
Intrapartum - Moderate and Severe Anaemia
World Maternal Antifibrinolytic Trial_2
Postpartum haemorrhage (PPH) is responsible for about 100,000 maternal deaths every year, almost all of which occur in low and middle income countries.
- Trial name
- WOMAN-2 (NCT03475342)
- Testing
- Tranexamic Acid
- Where
- 41 sites in Nigeria, Pakistan and 2 more
- Volunteers
- 15,068 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Hemophilia and Other Severe Bleeding Disorders
Swiss Hemophilia Registry
The Swiss Hemophilia Registry will collect data on the prophylactic and therapeutic use of factor concentrates in patients with hemophilia and other severe bleeding disorders in Switzerland.
- Trial name
- NCT02512250
- Testing
- Registry
- Where
- 19 sites in Switzerland
- Volunteers
- 900 people
- Sponsor
- Swiss Hemophilia Network
Trauma
Rotational Thromboelastometry Activated Transfusion In Trauma Trial
This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and…
- Trial name
- ROTATE-IT (NCT03765866)
- Testing
- Thromboelastometry guided transfusion
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Texas Southwestern Medical Center
Hemophilia A
BAX 855 Continuation
To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.
- Trial name
- NCT01945593
- Testing
- BAX855
- Where
- 89 sites in United States, Australia and 21 more
- Volunteers
- 218 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
Evaluate Efficacy and Safety of Recombinant Factor VIII （rFVIII）Treatment of Severe or Moderately Severe Hemophilia A
Efficacy, Safety and Pharmacokinetics Study of a rFVIII in Chinese subjects with Hemophilia A.To assess efficacy and safety of rFVIII administered as treatment and as on-demand therapy in adult and adolescent (12-65 years)…
- Trial name
- NCT02930317
- Testing
- Recombinant Factor VIII (50 IU/kg), Recombinant Factor VIII (On-demand treatment)
- Where
- 4 sites in China
- Volunteers
- 60 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hemophilia A With Inhibitor, Hemophilia A Without Inhibitor
Pharmacokinetic-guided Dosing of Emicizumab
The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of…
- Conditions
- Hemophilia A With Inhibitor, Hemophilia A Without Inhibitor, Hemophilia A, Severe, Adolescent
- Trial name
- DosEmi (NCT06320626)
- Testing
- Emicizumab - PK-guided dose reduction, Emicizumab - Dosis continuation group, Emicizumab - Dose adjustment group
- Where
- 8 sites in Netherlands
- Volunteers
- 95 people
- Sponsor
- Kathelijn Fischer
Aneurysmal Subarachnoid Haemorrhage, World Neurosurgeon Federation Score ≥ III
Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients
Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World Neurosurgeon Federation Score ≥ III
- Trial name
- SPLASH (NCT01801800)
- Testing
- Echocardiography
- Where
- 2 sites in France
- Volunteers
- 80 people
- Sponsor
- Nantes University Hospital
Hemophilia A
Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.
- Trial name
- NCT01810666
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 5 sites in China
- Volunteers
- 30 people
- Sponsor
- Bayer
Severe Trauma (With or Without Traumatic Brain Injury)
Post Traumatic Critical Complications: a Prospective Cohort Study (ATLANREA)
The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma.
- Trial name
- NCT02426255
- Testing
- Collection of medical data from ICU patients
- Where
- 5 sites in France
- Volunteers
- 5,000 people
- Sponsor
- Nantes University Hospital
Glanzmann Thrombasthenia
Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)
This study is evaluating an investigational drug, eptacog beta (EB), for the treatment and prevention of acute bleeding episodes in people with Glanzmann Thrombasthenia, a rare inherited bleeding disorder.
- Trial name
- STRENGTH (NCT07136857)
- Testing
- EPTACOG BETA
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Emory University
Shock, Hemorrhagic, Shock, Traumatic
Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients
MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid.
- Conditions
- Shock, Hemorrhagic, Shock, Traumatic, Acidosis, Lactic
- Trial name
- NCT01262196
- Testing
- MP4OX, Saline
- Where
- 40 sites in Australia, Austria and 12 more
- Volunteers
- 348 people
- Sponsor
- Sangart