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Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery

NCT02063035 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-06-08

Study results available
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Summary

Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure.

Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels.

Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.

Conditions

  • Lumbar Spinal Stenosis
  • Thoracic Spinal Stenosis

Interventions

DRUG

Tranexamic Acid

A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.

DRUG

Placebo

A single topical application of matching placebo, which is 100 mL of normal saline.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Kirkham B Wood, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-04-22
Completion
2015-04-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02063035 on ClinicalTrials.gov