Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000567426
Ethics application status
Approved
Date submitted
15/10/2007
Date registered
5/11/2007
Date last updated
16/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 252455 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The efficacy to reverse the effect of warfarin by prothrombinex alone 2385 0
Condition category
Condition code
Blood 2488 2488 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The subject will receive Prothrombinex-50units/kg body weight as an intravenous infusion.
Intervention code [1] 2108 0
Treatment: Drugs
Comparator / control treatment
If INR (internationlised ratio) is still >2, 300mls of fresh frozen plasma will be administrated intravenously.
Control group
Active

Outcomes
Primary outcome [1] 3385 0
The rapid reversal of Warfarin and defined by INR<2 (internationalised ratio reflects the level of warfarin)
Timepoint [1] 3385 0
30 minutes post administration of prothrombinex-VF
Secondary outcome [1] 5618 0
Safety outcomes:
allergic reaction to Prothrombinex
the development of a complication with prothrombinex-VF namely thrombosis
Timepoint [1] 5618 0
day 30 post administration of prothrombinex

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 282 0
3199

Funding & Sponsors
Funding source category [1] 2707 0
Hospital
Name [1] 2707 0
Frankston Hospital
Country [1] 2707 0
Australia
Primary sponsor type
Hospital
Name
Frankston Hospital
Address
Hastings Road
Frankston
Victoria 3199
Country
Australia
Secondary sponsor category [1] 2452 0
None
Name [1] 2452 0
Address [1] 2452 0
Country [1] 2452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4627 0
Peninsula Human Research & Ethic Committee
Ethics committee address [1] 4627 0
Hastings Road
Frankston
Victoria 3199
Ethics committee country [1] 4627 0
Australia
Date submitted for ethics approval [1] 4627 0
12/09/2007
Approval date [1] 4627 0
Ethics approval number [1] 4627 0
2007-37
Ethics committee name [2] 4628 0
Ethics committee address [2] 4628 0
Ethics committee country [2] 4628 0
Date submitted for ethics approval [2] 4628 0
12/09/2007
Approval date [2] 4628 0
Ethics approval number [2] 4628 0
2007-37

Summary
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
Trial website
Trial related presentations / publications
Annals of Emergency Medicine
Public notes

Contacts
Principal investigator
Name 28061 0
Address 28061 0
Country 28061 0
Phone 28061 0
Fax 28061 0
Email 28061 0
Contact person for public queries
Name 11218 0
Dr Barry Chan
Address 11218 0
Frankston Hospital
Hastings Road
Frankston
Victoria 3199
Country 11218 0
Australia
Phone 11218 0
61-3-97847777
Fax 11218 0
Email 11218 0
[email protected]
Contact person for scientific queries
Name 2146 0
Dr Barry Chan
Address 2146 0
Hastings Road
Frankston
Victoria 3199
Country 2146 0
Australia
Phone 2146 0
61-3-97847777
Fax 2146 0
Email 2146 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.