drugset
drugset / Trial / NCT04797156

Combined IV and Topical TXA in Major Spine Surgery

NCT04797156 ↗

Phase 0 Completed 65 enrolled Icahn School of Medicine at Mount Sinai
RandomizedFactorialTriple-blindTreatment

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.

Timeline

Start
2021-03-03
Primary completion
2024-08-15
Completion
2024-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 5 mg/kg Intravenous
Subject Tranexamic Acid Small molecule 2 g Intravenous

Indications

No indication recorded.