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

Northwestern University61 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Curvature of Spine

Interventions

Tranexamic AcidDRUG

intravenous administration of bolus and infusion for duration of surgical procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Total Red Blood Cells Transfused in the Intraoperative Period

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

Time frame: Intraoperative period (approximately 12 hours)

Secondary Outcomes

Additional Blood Products Transfused

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

Time frame: 24 hours after skin incision

Post Operative Major Morbidity

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.

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

Data from ClinicalTrials.gov

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