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

Survey of Low-dose Heparin, Enoxaparin and Rivaroxaban as Prophylaxis against Venous Thromboembolism in Moderate to Severe Traumatic Brain Injury: A Randomized Clinical Trial Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230705058684N1

Enrollment

Registered

2023-08-01

Start date

2023-10-07

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Moderate to Severe Traumatic Brain Injury. Injuries to the head

Interventions

Intervention 1: Intervention group: Heparin receiving group. Intervention 2: Intervention group: Enoxaparin receiving group. Intervention 3: Intervention group: Rivaroxaban receiving group.

Eligibility

Sex/Gender

All

Age

16 Years to 70 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadhosain Afrand

Birjand University of Medical Sciences

Hosain.afrand@yahoo.com+98 35 3723 7280

Outcome results

None listed

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