15 completed, 3 recruiting, 2 terminated, 2 unknown. 7 Phase 2, 6 Phase 3, 4 Phase 4, 2 Not applicable, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 6, Terminated 1 |
| Phase 3 | 6 | Completed 3, Withdrawn 2, Recruiting 1 |
| Phase 4 | 4 | Completed 3, Unknown 1 |
| Not applicable | 2 | Completed 1, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
Follow Afibrinogenemia: new trials by email Literature Review of Afibrinogenemia trials Research Report on Afibrinogenemia
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 |
|---|---|---|---|---|---|---|
| Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage Pathogen Reduced Cryoprecipitated Fibrinogen Complex - Hypofibrinogenemia, Hemorrhage | Enrolling by invitation | Cerus Corporation | 320 | 2026-09-15 | 2026-10-14 | |
| Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department Trauma Induced Coagulopathy, Trauma Coagulopathy | Recruiting | Erasmus Medical Center | 50 | 2025-11-01 | 2026-10-06 | |
| Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery CSL511 Fibrinogen concentrate (human), Cryoprecipitate - Acquired Fibrinogen Deficiency | Phase 3 | Recruiting | CSL Behring | 90 | 2024-10-01 | 2026-10-13 |
| A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery the Electrochemical-based device - Hypofibrinogenemia | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 150 | 2024-06-01 | 2025-05-15 | |
| FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis FIB Grifols - Congenital Afibrinogenemia, Hypofibrinogenemia | Phase 3 | Withdrawn | Instituto Grifols, S.A. | 2023-12-01 | 2023-10-23 | |
| Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding Traditional Cryoprecipitate, Pathogen-Reduced Cryoprecipitate - Hypofibrinogenemia, Bleeding | Phase 4 | Completed | Weill Medical College of Cornell University | 208 | 2023-04-01 | 2025-11-21 |
| Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness FibCLOT, RiaSTAP - Hypofibrinogenemia, Surgical Blood Loss | Phase 2 | Completed | IRCCS Policlinico S. Donato | 40 | 2023-03-20 | 2024-02-28 |
| Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence Clinical Decision Support - Anemia, Thrombocytopenia | Not applicable | Completed | University of Utah | 1543 | 2023-02-01 | 2025-03-06 |
| ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery Fibrinogen Concentrate Human, Prothrombin Complex Concentrate, Fresh Frozen Plasma - Bleeding, Cardiac Defect | Phase 2 | Terminated | IRCCS Policlinico S. Donato | 40 | 2020-02-27 | 2021-11-03 |
| Pregnancy and Fibrinogen Disorders Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital | Completed | University Hospital, Geneva | 149 | 2019-09-01 | 2022-11-02 | |
| 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 |
| F-Point Validation Study F-Point - Low Fibrinogen | Unknown | Royal College of Surgeons, Ireland | 150 | 2018-05-14 | 2018-08-09 | |
| Adjusted Fibrinogen Replacement Strategy BT524, FFP/Cryo - Bleeding Disorder, Hypofibrinogenemia; Acquired | Phase 3 | Completed | Biotest | 222 | 2018-04-03 | 2025-06-13 |
| Human Fibrinogen Concentrate in Pediatric Cardiac Surgery RiaStAP, Saline - Hypofibrinogenemia, Afibrinogenemia | Phase 4 | Completed | Nicklaus Children's Hospital f/k/a Miami Children's Hospital | 30 | 2017-06-01 | 2021-09-16 |
| Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia Human Plasma-Derived Fibrinogen Concentrate - Congenital Afibrinogenemia | Phase 1 / Phase 2 | Completed | Grifols Therapeutics LLC | 24 | 2016-07-22 | 2022-03-31 |
| Quality of Life in Patients With Congenital Afibrinogenemia Questionnaire quality of life - Afibrinogenemia, Congenital | Completed | University Hospital, Geneva | 250 | 2016-06-01 | 2020-11-12 | |
| 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 |
| Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions ROTEM, Cryoprecipitate, RiaSTAP - Coagulopathy | Not applicable | Terminated | Weill Medical College of Cornell University | 19 | 2015-10-01 | 2019-01-15 |
| 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 |
| Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency biological: human fibrinogen concentrate - Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital | Phase 2 / Phase 3 | Completed | Laboratoire français de Fractionnement et de Biotechnologies | 16 | 2014-01-01 | 2016-02-12 |
Showing 20 of 25. Sign in to see all of them.
Hemorrhage (8) · Hemostatic Disorders (6) · Wounds and Injuries (4) · Blood Coagulation Disorders (2) · Heart Defects, Congenital (2) · Abortion, Spontaneous (1) · Anemia (1) · Blood Loss, Surgical (1) · Dysfibrinogenemia, Congenital (1) · Heart Diseases (1) · Hemophilia B (1) · Lymphoma, Follicular (1) · Postoperative Hemorrhage (1) · Pseudomyxoma Peritonei (1)
Blood Coagulation Disorders, Inherited (25) · Coagulation Protein Disorders (25) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (25) · Genetic Diseases, Inborn (25) · Hematologic Diseases (25) · Hemic and Lymphatic Diseases (25) · Hemorrhagic Disorders (25) · Blood Coagulation Disorders (23) · Cardiovascular Diseases (8) · Pathologic Processes (8) · Pathological Conditions, Signs and Symptoms (8) · Vascular Diseases (6) · Cardiovascular Abnormalities (2) · Congenital Abnormalities (2) · Heart Diseases (2)
Fibrinogen (10) · cryoprecipitate coagulum (4) · Saline Solution (2) · Factor IX (1) · Sodium Chloride (1)
CSL Behring (3) · Biotest (2) · IRCCS Policlinico S. Donato (2) · University Hospital, Geneva (2) · Weill Medical College of Cornell University (2) · Cerus Corporation (1) · Erasmus Medical Center (1) · Filomena R B G Galas (1) · Grifols Therapeutics LLC (1) · Hospices Civils de Lyon (1) · Instituto Grifols, S.A. (1) · Laboratoire français de Fractionnement et de Biotechnologies (1) · Nicklaus Children's Hospital f/k/a Miami Children's Hospital (1) · Octapharma (1) · Royal College of Surgeons, Ireland (1)
United States (9) · Italy (5) · France (4) · Lebanon (4) · Switzerland (4) · Germany (3) · India (3) · United Kingdom (3) · Brazil (2) · Bulgaria (2) · Canada (2) · Egypt (2) · Morocco (2) · Netherlands (2) · Poland (2)
Alessandro Casini, MD (2) · Marco Ranucci, MD (2) · Barto Nascimento, MD MSc (1) · Caroline van der Marel, MD, PhD (1) · Christopher Tirotta, MD (1) · Claudia Djambas Khayat, MD (1) · Filomena RG Galas (1) · Flora Peyvandi, MD (1) · Justine Hugon-Rodin, MD, PHD (1) · Lucas S Lucena, MD (1) · Melissa Cushing (1) · Niels Rahe-Meyer, Prof. (1) · Niki A. Ottenhof, MD, PhD (1) · Nikolaos J Skubas, M.D. (1)
PMID 17087729, PMID 19804533, PMID 24951020, PMID 25103301, PMID 27061783, PMID 33512441, PMID 34755760, PMID 35305111, PMID 36408876, PMID 39334317, PMID 39383100, PMID 40741224, PMID 41702298, PMID 42247815
2016 (1), 2017 (1), 2018 (1)