| Balfaxar (prothrombin complex concentrate, human-lans) / Octapharma, Pfizer |
2014-000392-33: Comparing fixed dosing versus individualized dosing of prothrombine complex concentrate in treating (possible) bleeding in users of vitamin K antagonists. |
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| Ongoing | 4 | 480 | Europe | Concentrate for solution for injection, Cofact (Sanquin) Beriplex (CSL Behring) Octaplex (Octapharma) | University Medical Center Groningen, University Medical Center Groningen, Sanquin | Major bleeding complications of vitamin K antagonists, Major bleeding in patients using vitamin K antagonists (acenocoumarol or phenprocoumon), Diseases [C] - Injuries, poisonings, and occupational diseases [C21] | | | | |
2007-000602-73: Efficacy and Safety of two doses regimens of Octaplex in patients with cerebral haemorrhage related to oral anticoagulant therapy: A phase IV, prospective, randomised, open-label study. |
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| Ongoing | 4 | 60 | Europe | OCTAPLEX, OCTAPLEX | OCTAPHARMA AG | Traitement des saignements et prophylaxie péri-opératoire des accidents hémorragiques en cas de déficit acquis en facteurs de coagulation du complexe prothrombique, notamment induit par les anti-vitamines K, quand une correction urgente du déficit est requise | | | | |
| Recruiting | 4 | 350 | Canada | Fibrinogen + PCC, Fibryga + Octaplex, Frozen Plasma | University Health Network, Toronto, Sunnybrook Health Sciences Centre, Octapharma, Canadian Institutes of Health Research (CIHR), Canadian Institute for Military and Veteran Health Research Defense Research & Development Canada | Traumatic Hemorrhage, Coagulopathy, Massive Hemorrhage | 12/23 | 01/24 | | |
| Recruiting | 3 | 260 | Europe, US, RoW | Octaplex | Octapharma, Octapharma AG | Acute Major Bleeding | 12/24 | 12/24 | | |
FARES-2, NCT05523297: Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery |
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| Completed | 3 | 419 | Canada, US | Octaplex, Frozen Plasma Product, Human | Octapharma | Bleeding Cardiac Surgery Patients | 06/24 | 06/24 | | |
2018-003041-41: Comparisons of two different blood products (callled fresh frozen plasma and prothrombin complex concentrate) in patients who are undergoing cardiac surgery and who develop major bleeding that requires treatment with blood product - a pilot randomised control trial. |
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| Not yet recruiting | 2 | 50 | Europe | OCTAPLEX, LG-Octaplas, Concentrate and solvent for solution for infusion, Solution for infusion, OCTAPLEX, LG-Octaplas | Queen Mary University of London, British Heart Foundation | Major bleeding during cardiac surgery not related to vitamin K antagonists, Bleeding during cardiac surgery, Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | | | | |
NCT06429787: Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure |
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| Not yet recruiting | N/A | 3574 | NA | Balfaxar, Kcentra | Octapharma | Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk | 12/31 | 06/32 | | |