Comparison of the effect of enoxaparin and aspirin on the prevention of deep vein thrombosis after spinal surgery

Comparison of the effects of enoxaparin and aspirin in preventing deep vein thrombosis after spine surgery

Clinical trial with control group with parallel groups, double blind, randomized on 100 patients. For randomization, restricted randomization was used .

A clinical trial with a control group with parallel groups, double-blind, randomized, is conducted on 100 patients who have undergone spinal surgery in Shahid Ghayab Hospital of Mashhad, and Caprini criteria of 5 and above have been obtained for them.In the intervention group, ASA is administered 24 hours after surgery, and in the control group, Enoxaparin is prescribed, and the occurrence of DVT is checked after 7 days. In this study, the evaluator, the analysts and the allocation of the sample data to the groups are blinded. Each patient is transferred to a group 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.

Patients aged 18 to 70 years who underwent spine surgery at Shahid Ghayab Hospital and have a Caprini score of 5 or more and did not have DVT or pulmonary embolism before the surgery

In the intervention group, aspirin tablets with a dose of 81 mg daily 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. 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. Subsequently, on the seventh day after surgery to diagnose DVT, the venous venous Doppler ultrasound is performed.

Occurrence or absence of DVT

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.

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

Totals of participants and outcome information are shared after de-identification of individuals

Access starts one year after results are published

The data will be available only to researchers working in academic and scientific institutions

The data will be available for use in scientific studies

َAmir Kavian, Neurosurgery resident,Shahid Kamyab hospital,Mashhad,Iran

Checking the identity of the data requester through the ID card and also checking the study that is going to be done.