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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Curvature of Spine

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period | Drug: Tranexamic Acid<br>* intravenous administration of bolus and infusion for duration of surgical procedure<br>* Other names: Lysteda;|
| Placebo Comparator: Placebo<br>Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course | Drug: Tranexamic Acid<br>* intravenous administration of bolus and infusion for duration of surgical procedure<br>* Other names: Lysteda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Intraoperative period (approximately 12 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Blood Products Transfused | Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units. | 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 of surgery to date of discharge from hospital (average 7 days) |