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

Phase 2

Completed

• Conditions: Curvature of Spine
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT01728636
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Study Start: 2013-01-15
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Results First Submitted: 2019-11-26
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Results First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic Acid	Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period
Placebo	Tranexamic Acid	Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course

Primary Outcome Measures

Name	Time	Method
Total Red Blood Cells Transfused in the Intraoperative Period	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 Outcome Measures

Name	Time	Method
Additional Blood Products Transfused	24 hours after skin incision	Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units.
Post Operative Major Morbidity	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.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States