Combined IV and Topical TXA in Major Spine Surgery

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Tranexamic Acid

Criteria

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