None listed
Conditions
Brief summary
Study Title An open label, phase IV clinical trial examining the efficacy of Prothrombinex alone versus Prothrombinex combined with fresh frozen plasma in patients who require Warfarin reversal Trial Objectives The primary aim of this study is to determine whether Prothrombinex alone is adequate and effective in the reversal of the anticoagulant activity of Warfarin. Number of patients 40 Inclusion Criteria 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. Exclusion Criteria 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. Objective criteria for study entry 1. Asymptomatic INR > 9 where there is a high risk of bleeding 2. Any clinically significant bleeding where Warfarin induced coagulopathy is considered a contributing factor and an INR >2.5 where Warfarin reversal is considered important by the clinician 3. Pre surgery if INR > 2.5 on day of surgery and the clinician requires reversal of the effects of Warfarin Outcomes The primary outcome is the rapid reversal of Warfarin as indicated by the correction of the INR to < 2. Safety outcomes: Allergic reaction to Prothrombinex, the development of a complicating thrombosis (venous or arterial) and the presentation of clinically overt bleeding
Interventions
The subject will receive Prothrombinex-50units/kg body weight as an intravenous infusion.
Sponsors
Frankston Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed