Prospective Randomized Controlled Trial Analyzing the Efficacy of Oral Administration of Tranexamic Acid in Spine Surgery.

N0421

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.

2021-01-01

2021-12-30

2022-01-01

Completed

Early phase I

60

Inclusion Criteria: * Patients of 40-70 years * Patients 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 data * Agree to sign the informed consent Exclusion Criteria: * Patients excluded were those with low preoperative hemogram values (Hb \<10mg/dL, low platelet counts (\<100 x 109/L) * Bleeding disorders, coagulopathies * Intake of contraceptives or anticoagulant medication * Active thromboembolic disease (deep venous thromboembolism, chronic venous insufficiency, chronic thromboembolism) * Fibrinolytic disorders secondary to consumption coagulopathy * History of thromboembolic or coronary disease * History of seizure * Liver failure * Dyslipidemia * Congenital coagulopathies (Von Willebrand Disease, Hemophilia A and B) * Acquired coagulopathy (Vitamin K deficiency, disseminated intravascular coagulation) * Thrombocytopenic purpura * Patients in whom postsurgical hemoglobin was not available, or patients who accidentally removed the drain or had leaks were eliminated from the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 randomized groups', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patients agreed to receive either placebo or medication, without knowing which they were getting', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-01-30