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Clinical Trials/ACTRN12607000567426
ACTRN12607000567426
Recruiting
Phase 4

An open label, phase IV clinical trial examining the efficacy of Prothrombinex-VF alone verses Prothrombinex-VF combined with fresh frozen plasma in patients who require Warfarin reversal.

Frankston Hospital0 sites40 target enrollmentNovember 5, 2007
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ConditionsThe efficacy to reverse the effect of warfarin by prothrombinex aloneBlood - Clotting disorders

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
The efficacy to reverse the effect of warfarin by prothrombinex alone
Sponsor
Frankston Hospital
Enrollment
40
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 5, 2007
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Frankston Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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