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.

Randomized controlled pilot trial on the timing of anticoagulation to prevent venous thromboembolism in patients with traumatic brain injury.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/016972

Enrollment

150

Registered

2019-01-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients sustaining traumatic brain injury

Interventions

Intervention1: enoxaparin: enoxaparin given at 48 hours after stabilization of intracranial haemorrhage Intervention2: enoxaparin: Enoxaparin will be started at 24 hours after stabilization of intracr

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
incidence of bleeding complications in the 24, 48 and 72 hour arms Timepoint: CT scans done at 48 hours and 96 hours provided no unscheduled scans were done within 12 hours of these mandatory scans.	—

Countries

India

Contacts

Public ContactMS Gopalakrishnan

Jawaharlal Institute of Post graduate Medical Education and Research

gopalakrishnanms@gmail.com9345141431

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026