Skip to main content
OpenTrials
Completed

NCT Number: NCT01728636

The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery

The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Curvature of Spine Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

There are conflicting studies in the literature reporting different efficacy outcomes for the use of antifibrinolytics in spine fusion surgery. Several studies support the successful use of tranexamic acid for major orthopedic procedures, but the patient populations studied for spine surgery thus far have been small and highly variable, with less than clinically significant results. If TXA if efficacious in reducing not only perioperative blood loss, but RBC transfusion without an increase in thromboembolic events, then its use may be justified for patients at risk for major blood transfusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age>17 years
  • undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of major transfusion

Exclusion criteria

  • age < 18 years
  • non-English speaking
  • pregnancy
  • emergency procedures
  • surgery for tumor, trauma or infection
  • severe coronary artery disease
  • history of venous thromboembolism
  • history of cerebral vascular accident
  • history of renal insufficiency
  • allergy to tranexamic acid

Treatment and study plan

Tranexamic Acid

Drug

intravenous administration of bolus and infusion for duration of surgical procedure

Other names: Lysteda

Primary outcomes

  1. Total Red Blood Cells Transfused in the Intraoperative Period

    Time frame: Intraoperative period (approximately 12 hours)

    Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion.

Secondary outcomes

  1. Additional Blood Products Transfused

    Time frame: 24 hours after skin incision

    Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units.

  2. Post Operative Major Morbidity

    Time frame: Time of surgery to date of discharge from hospital (average 7 days)

    Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge.

Other outcomes

  1. Estimated Intraoperative Blood Loss

    Time frame: Incision to skin closure (approximately 10 hours)

    Estimated Intraoperative blood loss in milliliters (mLs)

  2. Total Tranexamic Acid Dose (mg)

    Time frame: Intraoperative period

    Total milligrams of intravenous tranexamic acid administered during the surgical procedure.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: TXA

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2012
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.