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

• Status: Completed
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alejandro Reyes Sánchez
• Treatments: Tranexamic Acid

Criteria

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