Status:
UNKNOWN
Understanding Risk Factors Involved in Developing a Second Blood Clot.
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Biomerieux inc
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to develop a way to predict which patients diagnosed with idiopathic blood clots can safely stop warfarin therapy after six months. We will use patient characteristics, bl...
Detailed Description
The risk of recurrent VTE in patients with idiopathic VTE subsequent to three to six months of oral anticoagulant therapy remains high (5-27% per year). The risk of recurrent VTE, however, is not like...
Eligibility Criteria
Inclusion
- Objectively proven (as previously described (8)) proximal idiopathic deep vein thrombosis or pulmonary embolism. Idiopathic will be defined as VTE occurring in the absence of fracture, plaster cast, immobilization greater than 3 days or a general anesthetic in the last three months prior to VTE diagnosis; a known deficiency of antithrombin, protein C or protein S; and malignancy in the last five years
- Patients treated initially with a minimum of five days of heparin or low molecular weight heparin and oral anticoagulants with a target intensity of 2.0 - 3.0 with no recurrence in the subsequent six months.
- Patients currently on oral anticoagulants
Exclusion
- Recurrent idiopathic VTE (i.e. \≥ 2 previous idiopathic VTE). Previous secondary VTE is not an exclusion criterion;
- Age \<18;
- Known deficiency of proteins S, protein C or antithrombin;
- Known, persistently positive anticardiolipin antibodies (titers \> 30U/ml);
- Known, persistently positive lupus anticoagulant;
- Combined thrombophilic defects (e.g. homozygous for FVL or PGM, or compound heterozygous for FVL and PGM);
- Refusal of informed consent.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00261014
Start Date
October 1 2002
End Date
March 1 2016
Last Update
November 18 2015
Active Locations (7)
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1
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
2
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
3
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
4
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4