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IRCT20230705058684N1 IRCT 2023-08-01 Birjand University of Medical Sciences 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 2023-10-07 anticipated 60 Complete https://irct.ir/trial/71429 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random allocation is done using 6 permutation blocks, individually and by a sealed envelope, Blinding description: Due to the low level of consciousness, the patients do not know about the type of medicine they received (due to the fact that all three drugs are common in preventing the intended outcome in the study, it does not create a problem from an ethical point of view). According to the randomization of the sampling of 6 substitution type, the healthcare personnel and the doctor in charge of the patient are not involved in the choice of medicine and are blinded. The person in charge of data collection did not interfere in the selection of the drug for the reasons mentioned, and blinding was done. 2 Moderate to Severe Traumatic Brain Injury. Intervention 1: Intervention group: Heparin receiving group. Intervention 2: Intervention group: Enoxaparin receiving group. Intervention 3: Intervention group: Rivaroxaban receiving group. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions Conditions: All statistical information will be available without limitation Where to obtain: Mohammadhosain Afrand Address: Ghaem Alley 2; Ghaem Ave; Azadshahr; Yazd Zip Code:8917145438 Tel: 00983537237280 Mobile:00989131545369 Email: hosain.afrand@yahoo.com How to obtain: They will receive the data by email to the person in charge of the project Comments:
public Mohammadhosain Afrand
Taleghani
Birjand Iran (Islamic Republic of) 8917145438 +98 35 3723 7280 Hosain.afrand@yahoo.com Birjand University of Medical Sciences scientific Mohammadhosain Afrand
Taleghani
Birjand Iran (Islamic Republic of) 8917145438 +98 35 3721 7280 Hosain.afrand@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) 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 16 years 70 years Both S00-S09 Injuries to the head Prevention Prevention Prevention Intervention group: Heparin receiving group Intervention group: Enoxaparin receiving group Intervention group: Rivaroxaban receiving group 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. 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. Birjand University of Medical Sciences Approved 2023-07-03 Ethics committee of Birjand University of Medical Sciences Taleghani Ave., Emam Reza (AS) Hospital, Birjand, Southern Khorasan Province, Iran Birjand South Khorasan Iran (Islamic Republic of)