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IRCT20200207046400N1 IRCT 2020-06-13 Esfahan University of Medical Sciences efficacy of early and late term imitation of prophylactic enoxaparin in prevention of thrombotic event and prevalence of hemorrhagic complications in patients with chronic subdural hematoma Comparative efficacy of early and late term imitation of prophylactic enoxaparin in prevention of thrombotic event and prevalence of hemorrhagic complications in patients with chronic subdural hematoma treated with Burr-hole craniostomy approach 2020-03-20 anticipated 30 Complete https://irct.ir/trial/47192 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the patients will be randomly allocated using statistical software.then they will be assigned into two major arms of study,early and late-enoxaparin administration, Blinding description: In this study, after explaining the goals to the patient, he is given informed consent. Patients are randomly divided into two groups, but neither group is aware of which group. The researcher does not know which group each patient belongs to. However, the clinical caregiver is aware of the group of patients and uses the drug in accordance with the group in which the patient is placed. 3 Chronic subdural haematoma. Intervention 1: Intervention group: Enoxaparin with a prophylactic dose 24 hours per day at a dose of 1 mg / kg (maximum 40 mg). Intervention 2: Control group: Enoxaparin with a prophylactic dose 72 hours per day at a dose of 1 mg / kg (maximum 40 mg). Yes - There is a plan to make this available What will be shared: Data can be shared after people become unrecognizable When: Start the access period 6 months after printing the results To whom: Researchers working in academic institutions Conditions: Just for study and new research people Where to obtain: Email Author responsible:Mehdishafiei82@gmail.com How to obtain: in first step,the request should be sent to corresponding author .the reasons, affiliations and authenticity of request will be investigated by author. then with concealing the personal data of patients due to privacy concerns and ethical issues, requested data will be available in following 2 weeks after appeal. Comments:
public Dr Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Esfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences scientific Dr Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Esfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All patients who have been diagnosed with Chronic subdural haematoma who undergo surgical evacuation Patient consent no limit no limit Both contraindications to receive enoxaparin occurrence of existence of deep venous thrombus in the period of study existence of hematoma in post operative brain CT scan I62. 03 Chronic subdural haematoma Treatment - Drugs Treatment - Drugs Intervention group: Enoxaparin with a prophylactic dose 24 hours per day at a dose of 1 mg / kg (maximum 40 mg) Control group: Enoxaparin with a prophylactic dose 72 hours per day at a dose of 1 mg / kg (maximum 40 mg) Bleeding events (epidural and cerebral hematoma). Timepoint: 24 , 72 hours after surgery by craniotomy. Method of measurement: Brain CT scan. Thrombotic events. Timepoint: 24 , 72 hours after surgery by craniotomy. Method of measurement: Double-sided Doppler ultrasound of the lower extremities. Esfahan University of Medical Sciences Approved 2020-01-21 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib St., Esfahan Isfehan Iran (Islamic Republic of)