CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 177 enrolled
Drug / intervention
Tranexamic Acid +2 moredrug
Likely dose
Tranexamic Acid 10mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00958581
NCT00958581Phase 4Completed
CompareCT.gov

A Prospective, Randomized, Double-blinded Single-site Control Study Comparing Blood Loss Prevention of Tranexamic Acid (TXA) to Epsilon Aminocaproic Acid (EACA) for Corrective Spinal Surgery

NYU Langone Health·interventional·Posted Aug 13, 2009·Updated Jan 17, 2018

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid, Normal Saline, and 1 other intervention for Scoliosis. Completed, enrolled 177 participants across 1 site.

Detailed Summary

Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood loss in the cardiac surgery literature but they have not been reported in use head-to-head in the orthopedic surgery literature. In a randomized, double-blind, prospective study we believe that TXA will be more effective than both EACA and placebo at reducing blood loss for corrective spinal surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScoliosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2009
Enrollment StartDec 1, 2008
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.9 years ago

Interventions

Tranexamic Aciddrug

For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.

Normal Salinedrug

Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose.

Epsilon aminocaproic aciddrug

For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.