A clinical trial studying if the 10mg initiation dose achieves anticoagulation faster than the 5mg initiation dose in the treatment of acute deep vein thrombosis, while maintaining safety and efficacy.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Acute Deep Vein Thrombosis
- Registration Number
- CTRI/2016/10/007346
- Lead Sponsor
- Fluid Research Grant Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
All patients, 18 years or older, with acute deep vein thrombosis being started on oral anticoagulation therapy by the division of surgery who consent to participation in the trial
Exclusion Criteria
1.Weight <40kgs
2.Underlying liver, renal disease
3.Recent treatment with any anticoagulants (within the preceding 5 days), Baseline INR >1.4
4.Pre-existing bleeding diatheses.
5.Diagnosed pulmonary embolism
6.Special patients eg pregnancy, children
7.Non consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to therapeutic INR (confirmed by two consecutive readings of between 2 to 3 at least 24 hours apart)Timepoint: Daily INR will be checked from day 3 onwards
- Secondary Outcome Measures
Name Time Method Bleeding or over-anticoagulation(INR8.0)Timepoint: any point during study;DeathTimepoint: any point during study;Failure to anticoagulate (Failure to achieve adequate anticoagulation despite maximum possible trial dose for three consecutive days)Timepoint: Day 5 onwards