A open label, phase IV clinical trial examining the efficacy of Prothrombinex alone verses Prothrombinex combined with fresh frozen plasma in patients who require Warfarin reversal.
- Conditions
- The efficacy to reverse the effect of warfarin by prothrombinex aloneBlood - Clotting disorders
- Registration Number
- ACTRN12607000567426
- Lead Sponsor
- Frankston Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1. Patients who are on Warfarin therapy with an asymptomatic INR >9 where the treating clinician wishes to reverse the effects of the drug
2. Any clinically significant bleeding where Warfarin induced coagulopathy is considered a contributing factor and an INR of >2.5 where Warfarin reversal is considered important by the clinician
3. Pre surgery if INR >2.5 on the day of surgery and the clinician requires reversal of the effects of Warfarin
4. Patient is = 18 years of age.
5. Patients that are able to understand and apply with study protocol requirements and instructions and intends to complete the study as planned.
6. Patient signs and dates written informed consent.
1.Active bleeding requiring blood transfusion.
2.Patients with a known allergy to prothrombin complex concentrates or fresh frozen plasma.
3.Participation in another pharmacotherapeutic study within 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rapid reversal of Warfarin and defined by INR<2 (internationalised ratio reflects the level of warfarin)[30 minutes post administration of prothrombinex-VF]
- Secondary Outcome Measures
Name Time Method Safety outcomes:<br>allergic reaction to Prothrombinex<br>the development of a complication with prothrombinex-VF namely thrombosis[day 30 post administration of prothrombinex]