Octaplex (human prothrombin complex concentrate) / 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 | | | | |
| Withdrawn | 4 | 0 | Europe | PCC, Octaplex, Riastab, FFP, Octaplas | Helsinki University Central Hospital | Postpartum Haemorrhage | 10/18 | 10/18 | | |
| 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 | | |