This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements. The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 16 weeks, 1 year, and 2 year) time points.
Reducing perioperative blood loss is critically important in the treatment of multiply injured combat casualties, and major blood loss during complex spine trauma surgery is a significant concern. Similar to previous studies in dental, cardiac, and total knee arthroplasty procedures, the use of topical tranexamic acid during complex combat related spine trauma surgery can be a cost-effective and simple route of administration to reduce blood loss, with no significant systemic effects. Patients would be expected to benefit immediately by decreasing blood loss and the need for blood transfusion postoperatively, thereby exposing them to less risk of transfusion reactions or disease transmission. This may also potentially decrease the rate of surgical site infection because patients have been found to have a significantly increased risk for surgical site infection after blood transfusion due to changes in the immune system, and by also decreasing the amount of blood that collects under the surgical wound, which serves as excellent medium for bacterial growth. The goal of the investigators study is to determine if the use of topical tranexamic acid (TXA) in the setting of complex spine surgery reduces blood loss, and subsequently reduces the rate of allogenic blood transfusion and surgical site infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
252
3.0 grams of tranexamic acid will be poured in the surgical field and left in contact for five minutes. Subsequently, excess study solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation. TXA solution will be prepared using a dose of 3 grams of tranexamic acid combined with 70 mL of sterile normal saline, for a total volume of 100 mL.
Placebo will be poured in the surgical field and left in contact for five minutes. Subsequently, excess solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation. The placebo solution will be 100 mL of sterile normal saline.
University of California San Francisco Medical Center
San Francisco, California, United States
RECRUITINGNorton Leatherman Spine Center
Louisville, Kentucky, United States
RECRUITINGNYP/The Allen Hospital - CUIMC
New York, New York, United States
RECRUITINGDuke University Medical Center
Durham, North Carolina, United States
RECRUITINGMaximal drop in systemic hemoglobin concentration during the postoperative period
Time frame: Patients will be followed through postoperative day 4
Reduction in the rate of surgical site infections
Defined by decreasing the allogenic transfusion rate (an independent risk factor for surgical site infections) as well as by decreasing the formation of postoperative hematoma (a nidus for infection).
Time frame: Duration of the hospital stay (an average of 2 weeks), first postoperative wound check visit
Number of complications
Defined as thromboembolic event, including deep vein thrombosis (DVT) or pulmonary embolism (PE)
Time frame: Up to postoperative day 4
Systemic absorption of locally applied drug
Time frame: Baseline (pre-surgery), immediately after administration of the topical agent, 1 hour after administration
Patient assessed health-related quality of life score
This will be determined by a questionnaire/score
Time frame: Up to 2 years postoperation
Difference in costs for hospital stay between using tranexamic acid and placebo
Patient cost information will be gathered for the duration of the hospital stay
Time frame: Duration of the hospital stay (an average of 2 weeks)
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