ow-dose Heparin, Enoxaparin and Rivaroxaban as Prophylaxis against Venous Thromboembolism in Moderate to Severe Traumatic Brain Injury

Phase 2

Conditions: Moderate to Severe Traumatic Brain Injury.
Injuries to the head
S00-S09

Registration Number: IRCT20230705058684N1

Lead Sponsor: Birjand University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

Moderate to Severe Traumatic Brain Injury
Age between 16 and 70
Latency time between injury and entering the study of less than 6 h
Without history of coagulopathy
Caprini Score of 3 or greater
Closed head injury
Glasgow Coma Scale (GCS) between 3 and 13
AIS (Abbreviated Injury Score 3 or less than 3

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DVT. Timepoint: Lower Doppler ultrasound will be performed within 24 hours of admission to determine the presence of DVT before or at the time of admission, as well as at the time of discharge or ten days after trauma (the highest incidence of thromboembolism in trauma patients) or based on the indication and diagnosis of the therapist (in case of suspicion of thromboembolism based on symptoms). DVT diagnosis will be done with Doppler ultrasound and with ultrasound of the popliteal, saphenous, femoral and iliac veins. Method of measurement: DVT diagnosis will be done with Doppler ultrasound and with ultrasound of the popliteal, saphenous, femoral and iliac veins.;PE. Timepoint: Diagnosis of PE will be done with spiral CT angiography of the lungs and if indicated. Method of measurement: Spiral CT angiography of the lungs.

Secondary Outcome Measures

Name	Time	Method
Glasgow coma scale between 3 and 13. Timepoint: Daily. Method of measurement: Clinical condition of the patient.;Intracranial Hematoma. Timepoint: According to the clinical presentation. Method of measurement: Brain CT- Scan.