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.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/10/007346
• Date of registration: 06-10-2016
• Prospective Registration: No
• Primary sponsor: Fluid Research Grant Christian Medical College Vellore
• Public title: 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.
• Scientific title: 10mg versus 5mg initiation dose of Warfarin to achieve adequate anticoagulation in the treatment of acute deep vein thrombosis - A Randomized Control Trial
• Date of first enrolment: 01-03-2014
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8754
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Srujan Lam Sharma
• Affiliation: Christian Medical College, Vellore

• Name: Sukria Nayak
• Affiliation: Christian Medical College, Vellore

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Acute Deep Vein Thrombosis

Intervention(s)

Intervention1: 10mg oral dose initiation nomogram: All patients in this arm will receive 10mg warfarin on day 1 and day 2 and dosage will be adjusted based on INR value from day 3 until a primary or secondary end point is reached All patients in this arm will receive 5mg warfarin on day 1 and day 2 and dosage will be adjusted based on INR value from day 3 until a primary or secondary end point is reached based on a predesigned nomogram.
Control Intervention1: 5mg oral dose initiation nomogram: All patients in this arm will receive 5mg warfarin on day 1 and day 2 and dosage will be adjusted based on INR value from day 3 until a primary or secondary end point is reached based on a predesigned nomogram.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

Fluid Research Grant, Christian Medical College, Vellore

Ethics review

Status: Approved
Approval date: 04/03/2014
Contact:

Instiutional Review Board and Ethics Committee, Christian Medical College, Vellore