CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Tranexamic Acid +3 moredrug
Likely dose
Not stated in 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/NCT04272606
NCT04272606Phase 2Completed
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Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation

Catherine R. Olinger·interventional·Posted Feb 17, 2020·Updated Dec 12, 2024

In Brief

A Phase 2 clinical trial evaluating Tranexamic Acid, Saline Solution, and 2 other interventions for Degenerative Disc Disease. Completed, enrolled 123 participants across 1 site.

Detailed Summary

Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Disc Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartAug 1, 2020
Primary CompletionJun 12, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.4 years ago

Interventions

Tranexamic Aciddrug

Antifibrinolytic Agent

Saline Solutiondrug

Placebo

Visual Acuity Examother

Supplemented into standard of care daily neurological exam on day of surgery and day after

3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)other

3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.