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

Northwestern University

Status and phase: Completed; Phase 2

Conditions: Curvature of Spine

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01728636

STU00066949

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course

Treatment:

Drug: Tranexamic Acid