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TXA in Spinal Fusion

NCT04272606 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2024-12-12

Study results available
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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.

Conditions

  • Degenerative Disc Disease

Interventions

DRUG

Tranexamic Acid

Antifibrinolytic Agent

DRUG

Saline Solution

Placebo

DIAGNOSTIC_TEST

Visual Acuity Exam

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

DIAGNOSTIC_TEST

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

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

Sponsors & Collaborators

  • Catherine R. Olinger

    lead OTHER

Principal Investigators

  • Catherine Olinger, M.D. · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-06-12
Completion
2023-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04272606 on ClinicalTrials.gov