The Effect of Combined Intravenous and Topical TXA in Major Multilevel Spine Surgery: A Prospective Randomized Trial

GCO 19-1137

This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital. Specifically, the study team will compare tranexamic acid given only intravenously vs. given both topically and intravenously vs. given only intravenously but at a higher dosage. The study team hypothesizes that patient who received combined topical and intravenous TXA (low dose) have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone.

2021-03-03

2024-11-01

2024-12-01

Recruiting

Early phase I

65

Inclusion Criteria: * Adults 18-80 years old * Undergo major multilevel spine surgery (2-8 levels) * Male or female Exclusion Criteria: * ASA class V * Urgent or emergent surgery, * Morbid obesity * Patients with known coagulopathy disorder, hx of thromboembolic event \<1 year, renal insufficiency, hepatic dysfunction, serious cardiac disease * Patients with known allergy to TXA or receiving antiplatelet and/or anticoagulant drugs * Religious or other belief that limit blood transfusion, * Surgery duration more than 6 hours * Patient refusal or inability to consent

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups:\n\n1. High Dose Intravenous TXA (hTXA group)\n2. Low Dose Intravenous TXA (lTXA group)\n3. Combined Intravenous and Topical TXA group (cTXA group).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The patient, surgeon, and anesthesiologist in the case will be blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 65, 'type': 'ESTIMATED'}}

2023-11-13