Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)

Launched by THANAWAN LONGSUWAN · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effect of a medication called tranexamic acid, which is applied directly to the surgical area, to see if it can help reduce blood loss and the amount of fluid collected in drains after a specific type of back surgery known as minimally invasive transforaminal lumbar interbody fusion (MI-TLIF). The trial will compare patients who receive this medication to those who receive a placebo, which is an inactive substance.

To participate in this study, individuals must be between the ages of 30 and 80 and have certain degenerative spine issues that require this type of surgery. However, people who have had previous spinal surgeries, are at high risk for complications, or have certain medical conditions, such as severe kidney disease or a history of blood clots, will not be eligible. Participants can expect to be randomly assigned to receive either the medication or the placebo, and the trial aims to gather information that could improve recovery and outcomes for patients undergoing this surgery in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 30-80 years old
• • Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF
• Exclusion Criteria:
• • Revision surgery
• • Patients who had high risk of complication from TXA
• • History of seizure, PE, DVT, thromboembolic episode
• • History of TXA allergy
• • Patients who had high risk for bleeding
• • U/D : CKD stage more than IIIb (GFR\< 45 ml/min/1.73m2), hepatic disease, bleeding disorder
• • On anticoagulation drug or antiplatelet drug in 7 days before surgery
• • Abnormal coagulation profile (INR \> 1.5) or CBC (platelet \< 100000)