A clinical trial to study the best time for administration of anticoagulant in patients with traumatic brain injury for the prevention of deep vein thrombosis.

Phase 3

• Conditions: Health Condition 1: null- Patients sustaining traumatic brain injury

• Registration Number: CTRI/2019/01/016972
• Lead Sponsor: MS Gopalakrishnan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. All head trauma patients who had trauma within 24 hours of hospital admission in whom the treating doctor has excluded continuing bleeding.

2. All head trauma patients who have undergone one or more neurosurgical procedures in the last 24 hours in whom the treating doctor has excluded rebleeding at the operative site and there are no other sites of continuing bleeding.

Exclusion Criteria

1.Patientsâ?? â??whoâ?? â??areâ?? â??alreadyâ?? â??onâ?? â??anticoagulantsâ?? â??orâ?? â??antiplateletâ?? â??drugs

2.Patientsâ?? â??whoâ?? â??haveâ?? â??abnormalâ?? â??postoperativeâ?? â??bleeding detected during or after surgery.

3.Patientsâ?? â??whoâ?? â??areâ?? â??knownâ?? â??toâ?? â??haveâ?? â??bleedingâ?? â??disorders

4.Patientsâ?? â??whoâ?? â??haveâ?? â??beenâ?? â??onâ?? â??sequentialâ?? â??pneumaticâ?? â??compressionâ?? â??device

5.Patientsâ?? â??whoâ?? â??haveâ?? â??aâ?? â??knownâ?? â??historyâ?? â??orâ?? â??clinicalâ?? â??documentationâ?? â??ofâ?? â??VTE

6. Patients who are known to be allergic to heparin

7.Patientsâ?? â??whoâ?? â??areâ?? â??likelyâ?? â??toâ?? â??beâ?? â??dischargedâ?? â??withinâ?? â??sevenâ?? â??daysâ?? â??ofâ?? â??hospitalization

8. Moribundâ?? â??patientsâ?? â??whoâ?? â??areâ?? â??unlikelyâ?? â??toâ?? â??surviveâ?? â??sevenâ?? â??days

9. Pregnantâ?? â??patients

10. Pediatricâ?? â??patientsâ?? â??belowâ?? â??theâ?? â??ageâ?? â??ofâ?? â??12â?? â??years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of VTE when anticoagulation is initiated at 24, 48 and 72 hoursTimepoint: incidence of VTE when anticoagulation is initiated at 24, 48 and 72 hours

Secondary Outcome Measures

Name	Time	Method
incidence of bleeding complications in the 24, 48 and 72 hour arms <br/ ><br> <br/ ><br>Timepoint: CT scans done at 48 hours and 96 hours provided no unscheduled scans were done within 12 hours of these mandatory scans. <br/ ><br>