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IRCT20221014056171N1 IRCT 2023-01-25 Mashhad University of Medical Sciences Comparison of the effect of enoxaparin and aspirin on the prevention of deep vein thrombosis after spinal surgery Comparison of the effect of enoxaparin and aspirin on the prevention of deep vein thrombosis after spinal surgery 2022-11-21 anticipated 100 Complete https://irct.ir/trial/68109 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, restricted randomization using the random allocation rule is used.For this purpose, the total sample size is 100 people and each group is 50 people.For each person, one envelope is removed from the total number of envelopes, which is the group assigned to the patient, Blinding description: Each patient is transferred to a group (intervention or control) by a collaborator who has no knowledge of the patient and the treatment method, and the information is recorded in sealed envelopes. At the beginning of the prophylaxis treatment, the envelope is opened by the researcher and the medicine is prescribed. N/A Deep venous thrombosis. Intervention 1: Intervention group: In the intervention group, aspirin tablets with a daily dose of 81 mg are used orally.The administration of drugs starts 24 hours after the end of the surgery to prevent bleeding at the operation site and continues for 7 days after the operation.If the patient is hospitalized while taking the drug, the monitoring of drug use and side effects will be done by the researcher, and if the patient is not hospitalized, by one of the first-degree relatives trained by the researcher.In the use of drugs prescribed for patients, drugs of the same brand will be prescribed.After that, on the seventh day after surgery, a venous Doppler ultrasound of the lower limbs is performed to diagnose DVT.To minimize the error caused by the radiologist in performing ultrasound, all ultrasounds will be performed by an experienced radiologist. Intervention 2: Control group: In the control group, for the prevention of DVT, enoxaparin with a dose of 40 mg is prescribed as a subcutaneous injection for 7 days.Other measures are similar to the intervention group. Yes - There is a plan to make this available What will be shared: Totals of participants and outcome information are shared after de-identification of individuals When: Access starts one year after results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The data will be available for use in scientific studies Where to obtain: ŮŽAmir Kavian, Neurosurgery resident,Shahid Kamyab hospital,Mashhad,Iran How to obtain: Checking the identity of the data requester through the ID card and also checking the study that is going to be done. Comments:
public Amir Kavian
Fadayaneslam Ave.
Mashhad Iran (Islamic Republic of) 3747491666 +98 51 3802 6232 kavianam971@mums.ac.ir Mashhad University of Medical Sciences scientific Hossein Mashhadinejad
Fadayaneslam Ave.
Mashhad Iran (Islamic Republic of) 3747491666 +98 51 3802 6233 mashhadinejadh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 70 years who underwent spine surgery at Shahid Kamyab Hospital and the Caprini score is 5 or more and did not have DVT or pulmonary embolism before the surgery 18 years 70 years Both Lack of patient consent to enter the study I80.3 Phlebitis and thrombophlebitis of lower extremities, unspecified Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, aspirin tablets with a daily dose of 81 mg are used orally.The administration of drugs starts 24 hours after the end of the surgery to prevent bleeding at the operation site and continues for 7 days after the operation.If the patient is hospitalized while taking the drug, the monitoring of drug use and side effects will be done by the researcher, and if the patient is not hospitalized, by one of the first-degree relatives trained by the researcher.In the use of drugs prescribed for patients, drugs of the same brand will be prescribed.After that, on the seventh day after surgery, a venous Doppler ultrasound of the lower limbs is performed to diagnose DVT.To minimize the error caused by the radiologist in performing ultrasound, all ultrasounds will be performed by an experienced radiologist. Control group: In the control group, for the prevention of DVT, enoxaparin with a dose of 40 mg is prescribed as a subcutaneous injection for 7 days.Other measures are similar to the intervention group. Occurrence or absence of deep venous thrombosis. Timepoint: Color doppler venous ultrasound of the lower limbs 7 days after surgery. Method of measurement: Color doppler venous ultrasound of the lower limbs. Bleeding or hematoma at the surgical site. Timepoint: Seven days after surgery. Method of measurement: Observation and palpation by the researcher. Mashhad University of Medical Sciences Approved 2022-07-11 Ethics committee of Mashhad University of Medical Sciences Shahid Kamyab hospital , Fadayaneslam37474 Ave. , Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)