10 completed, 6 unknown, 1 withdrawn. 9 Phase 2, 4 Phase 3, 4 Phase 4, 2 Not applicable, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 5, Unknown 3, Withdrawn 1 |
| Phase 3 | 4 | Completed 4 |
| Phase 4 | 4 | Completed 3, Unknown 1 |
| Not applicable | 2 | Unknown 2 |
| Phase 1 | 2 | Completed 1, Withdrawn 1 |
Follow Fibrinogen concentrate: new trials by email Literature Review of Fibrinogen concentrate trials Research Report on Fibrinogen concentrate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy Fibrinogen concentrate, Standard trauma care - Trauma Induced Coagulopathy | Not applicable | Unknown | Unidade Local de Saude do Arco Ribeirinho | 52 | 2025-01-01 | 2024-09-19 |
| Fibrinogen Early In Severe Trauma StudY II Fibrinogen Concentrate, Cryoprecipitate - Trauma, Haemorrhagic Shock | Phase 3 | Completed | Australian and New Zealand Intensive Care Research Centre | 900 | 2022-11-21 | 2026-09-09 |
| A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH) fibrinogen concentrate, Placebo - Postpartum Hemorrhage | Phase 1 / Phase 2 | Withdrawn | Yale University | 2021-01-01 | 2021-03-15 | |
| Fibrinogen Concentrate In Children Cardiac Surgery 2 Fibrinogen Concentrate, control - C.Surgical Procedure; Cardiac, Blood Coagulation Disorders | Phase 4 | Unknown | Filomena R B G Galas | 42 | 2019-03-01 | 2019-03-21 |
| Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation Fibrinogen concentrate, Fresh Frozen Plasma - Humoral Rejection, Guillain-Barre Syndrome | Not applicable | Unknown | University Medical Centre Ljubljana | 20 | 2018-10-03 | 2019-01-11 |
| Fibrinogen Early In Severe Trauma studY Junior Fibrinogen Concentrate, Cryoprecipitate - Trauma, Hemorrhage | Phase 2 | Unknown | Gold Coast Hospital and Health Service | 44 | 2018-07-01 | 2020-06-29 |
| Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery Platelet transfusion, Fibrinogen concentrate - Congenital Heart Disease | Phase 2 | Unknown | Sahlgrenska University Hospital | 40 | 2018-03-14 | 2021-03-19 |
| Fibrinogen Early In Severe Trauma studY Fibrinogen Concentrate, Cryoprecipitate - Trauma, Haemorrhage | Phase 2 | Completed | Gold Coast Hospital and Health Service | 100 | 2016-12-01 | 2018-03-05 |
| Fibrinogen Concentrate vs Cryoprecipitate Fibrinogen Concentrate, Cryoprecipitate - Congenital Heart Disease | Phase 4 | Completed | Stanford University | 60 | 2016-03-01 | 2019-05-07 |
| Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial Fibrinogen concentrate - Trauma, Bleeding Disorder | Phase 4 | Completed | University of Sao Paulo General Hospital | 32 | 2015-12-01 | 2018-08-01 |
| Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency Octafibrin - Congenital Fibrinogen Deficiency | Phase 3 | Completed | Octapharma | 15 | 2015-12-01 | 2021-01-15 |
| Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST) Fibrinogen concentrate, Placebo Comparator - Trauma, Injury | Phase 1 / Phase 2 | Completed | Sunnybrook Health Sciences Centre | 50 | 2014-10-01 | 2016-04-14 |
| Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest fibrinogen concentrate - Proximal Aortic Dissection | Phase 2 | Unknown | Hongjia Zhang | 150 | 2013-07-01 | 2015-09-07 |
| Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial Fibrinogen Concentrate, Isotonic Saline - Postpartum Haemorrhage | Phase 2 / Phase 3 | Completed | Copenhagen University Hospital at Herlev | 249 | 2011-05-01 | 2013-09-20 |
| Haemocomplettan® P During Elective Complex Cardiac Surgery Haemocomplettan® P, Human albumin (Placebo) - Fibrinogen Deficiency in Complex Cardiac Surgery | Phase 2 / Phase 3 | Completed | Isala | 120 | 2011-02-01 | 2014-12-16 |
| Fibrinogen Concentrate In Children After Cardiac Surgery Fibrinogen concentrate, Cryoprecipitate - Cardiac Surgical Procedures, Blood Coagulation Disorders | Phase 2 | Completed | University of Sao Paulo | 63 | 2010-08-01 | 2013-01-04 |
| Fibrinogen as an Alternative to FFP in Aortic Surgery. Fibrinogen concentrate, Fresh Frozen Plasma - Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair | Phase 4 | Completed | University of Edinburgh | 20 | 2010-06-01 | 2017-01-31 |
Hemostatic Disorders (10) · Hemorrhage (7) · Wounds and Injuries (6) · Afibrinogenemia (3) · Blood Coagulation Disorders (2) · Heart Defects, Congenital (2) · Postpartum Hemorrhage (2) · Anti-Glomerular Basement Membrane Disease (1) · Guillain-Barre Syndrome (1) · Miller Fisher Syndrome (1) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (1) · Shock, Hemorrhagic (1) · Thrombosis (1)
Gold Coast Hospital and Health Service (2) · Australian and New Zealand Intensive Care Research Centre (1) · Copenhagen University Hospital at Herlev (1) · Filomena R B G Galas (1) · Hongjia Zhang (1) · Isala (1) · Octapharma (1) · Sahlgrenska University Hospital (1) · Stanford University (1) · Sunnybrook Health Sciences Centre (1) · Unidade Local de Saude do Arco Ribeirinho (1) · University Medical Centre Ljubljana (1) · University of Edinburgh (1) · University of Sao Paulo (1) · University of Sao Paulo General Hospital (1)
Australia (3) · Brazil (3) · Canada (1) · China (1) · Denmark (1) · India (1) · Iran (1) · Lebanon (1) · Netherlands (1) · New Zealand (1) · Slovenia (1) · Sweden (1) · United Kingdom (1) · United States (1)
Alastair Nimmo, MBChB (1) · Anne J. Wikkelsoe, MD (1) · Arash Afshari, MD (1) · Arno P Nierich, MD, PhD. (1) · Barto Nascimento, MD MSc (1) · Cristina Solomon, MD (1) · Filomena RG Galas (1) · Francisco Das Neves Coelho, MD (1) · Glyn D Williams, MBChB, FFA (1) · Hellen McKinnon Edwards, M.D. (1) · Hongjia Zhang, M.D. (1) · Jakob Stensballe, MD, PhD (1) · James Winearls, MBBS (1) · Jens Langhoff-Roos, MD, DmSc (1)
PMID 22805300, PMID 24951020, PMID 25586727, PMID 28241354, PMID 28549445, PMID 34755760, PMID 35508351, PMID 36163263, PMID 39768590, PMID 40420619
2009 (1)