Clinical trial NCT01728636: The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
Official title: The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Curvature of Spine
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Red Blood Cells Transfused in the Intraoperative Period
timeFrame: Intraoperative period (approximately 12 hours)
Secondary outcomes:
measure: Additional Blood Products Transfused
timeFrame: 24 hours after skin incision
measure: Post Operative Major Morbidity
timeFrame: Time of surgery to date of discharge from hospital (average 7 days)
Other outcomes:
measure: Estimated Intraoperative Blood Loss
timeFrame: Incision to skin closure (approximately 10 hours)
measure: Total Tranexamic Acid Dose (mg)
timeFrame: Intraoperative period
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Louanne M Carabini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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