drugset / Trial / NCT00168077
Prothrombin Complex Concentrate for Anticoagulant Reversal
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.
Timeline
- Start
- 2005-09
- Primary completion
- —
- Completion
- 2006-11
Publications
- Results Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost. 2008 Apr;6(4):622-31. doi: 10.1111/j.1538-7836.2008.02904.x. Epub 2008 Jan 15.
- Results Pabinger I, Tiede A, Kalina U, Knaub S, Germann R, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol. 2010 Mar;89(3):309-16. doi: 10.1007/s00277-009-0830-7. Epub 2009 Sep 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Beriplex P/N | Protein / enzyme biologic | 25 iu/kg | — |
| Subject | Beriplex P/N | Protein / enzyme biologic | 35 iu/kg | — |
| Subject | Beriplex P/N | Protein / enzyme biologic | 50 iu/kg | — |