Clinical Trial Analyzing the Efficacy of Oral Administration of Tranexamic Acid in Spine Surgery.

Conditions: Tranexamic Acid (TXA), Prospective Study, Evidence-based Medicine, Randomized Controlled Trial

Summary

Study design: Randomized control trial Purpose: Evaluate the efficacy of oral administration of tranexamic acid (TXA) in spine surgeries to achieve blood loss reduction.Methods. A total of 60 patients undergoing major surgery of the spine, were randomly assigned into 2 groups. Group 1 was assigned as the control group and the other one included oral administration of tranexamic acid 2 hours prior to surgery. Outcomes measures included intraoperative blood loss, postoperative blood loss, hematological parameters, blood transfusion needed, and surgical complications.

Eligibility Criteria

Inclusion Criteria:Patients of 40-70 yearsPatients undergoing major surgery (it was defined as "surgeries involving the intervention of more than 4 levels of the thoracolumbar spine, and with a diagnosis of failed back surgery or, deformities in the spine")Complete dataAgree to sign the informed consentExclusion Criteria:Patients excluded were those with low preoperative hemogram values (Hb <10mg/dL, low platelet counts (<100 x 109/L)Bleeding disorders, coagulopathiesIntake of contraceptives or anticoagulant medicationActive thromboembolic disease (deep venous thromboembolism, chronic venous insufficiency, chronic thromboembolism)Fibrinolytic disorders secondary to consumption coagulopathyHistory of thromboembolic or coronary diseaseHistory of seizureLiver failureDyslipidemiaCongenital coagulopathies (Von Willebrand Disease, Hemophilia A and B)Acquired coagulopathy (Vitamin K deficiency, disseminated intravascular coagulation)Thrombocytopenic purpuraPatients in whom postsurgical hemoglobin was not available, or patients who accidentally removed the drain or had leaks were eliminated from the study

Source: ClinicalTrials.gov (NCT05705336). StuddyBuddy aggregates publicly available trial information.