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

123678

The randomized controlled study which compare the efficacy outcomes (reducing blood loss and drainage output in patients) in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and received topical tranexamic acid injection in the surgical site to those who received placebo injection.

2024-07-01

2026-12-01

2026-12-01

Not yet recruiting

28

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ESTIMATED'}}

2024-05-24