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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04797156
Other study ID # GCO 19-1137
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 3, 2021
Est. completion date December 2024

Study information

Verified date November 2023
Source Icahn School of Medicine at Mount Sinai
Contact Daniel Amor, MD
Phone (973) 897-8540
Email daniel.amor@mountsinai.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
High Dose Tranexamic acid
50mg/kg IV TXA
Low Dose Tranexamic acid
20mg/kg IV TXA
Tranexamic acid Topical
2g topical TXA
Normal saline
Normal saline poured on wound

Locations

Country Name City State
United States Mount Sinai West Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hematocrit level The amount of post-operative blood loss during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Specifically, the hematocrit number difference between baseline and post-operative day 1, 2 and 3. Baseline and Post-operative day 1, 2 and 3
Secondary Post-operative drain output The amount of post-operative drain output (ml) during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Post-operative day 1, 2 and 3
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