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Combined IV and Topical TXA in Major Spine Surgery

NCT04797156 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

High Dose Tranexamic acid

50mg/kg IV TXA

DRUG

Low Dose Tranexamic acid

20mg/kg IV TXA

DRUG

Tranexamic acid Topical

2g topical TXA

DRUG

Normal saline

Normal saline poured on wound

Sponsors & Collaborators

Principal Investigators

  • Yan Lai, M.D. · Mount Sinai West and Morningside Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2024-08-15
Completion
2024-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797156 on ClinicalTrials.gov