CLINICAL TRIALS PROFILE FOR KCENTRA
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All Clinical Trials for KCENTRA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02270918 ↗ | Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra | Completed | Bristol-Myers Squibb | Phase 1 | 2014-11-01 | Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from blood that is used as an antidote to treat people with bleeding associated with taking the well-known anticoagulant warfarin. This is a Phase I, placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility apixaban anticoagulation with Kcentra. |
| NCT02270918 ↗ | Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra | Completed | CSL Behring | Phase 1 | 2014-11-01 | Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from blood that is used as an antidote to treat people with bleeding associated with taking the well-known anticoagulant warfarin. This is a Phase I, placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility apixaban anticoagulation with Kcentra. |
| NCT02270918 ↗ | Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra | Completed | Thomas Jefferson University | Phase 1 | 2014-11-01 | Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from blood that is used as an antidote to treat people with bleeding associated with taking the well-known anticoagulant warfarin. This is a Phase I, placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility apixaban anticoagulation with Kcentra. |
| NCT02429453 ↗ | FFP Versus PCC in Intracranial Hemorrhage | Withdrawn | University of Utah | N/A | 2015-04-01 | The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial. |
| NCT02557672 ↗ | PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding | Enrolling by invitation | CSL Behring | Phase 4 | 2016-08-01 | This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP? |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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