Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery

2017-0920

Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative/adjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.

2018-07-11

2025-03-01

2025-03-01

Recruiting

Early phase I

100

Inclusion Criteria: * Age 18-80 * Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae * + fusion to pelvis Exclusion Criteria: * Surgical factors: * Anterior Approach * Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration * Patients donating autologous blood preoperatively Patient factors: * Diagnosis of renal (Cr\>1.5 or CrCl \<30ml/min) or hepatic insufficiency (AST, ALT 2x upper limit of normal) * Diagnosis of seizure disorder or prior seizure * History of thromboembolic events (CVA, TIA, DVT, PE) if within 1 year of surgery * Hypercoagulability (e.g. antiphospholipid syndrome) * History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery * Atrial fibrillation * Concurrent anticoagulation therapy that cannot be discontinued within 3 days before surgery (Coumadin, plavix, LVX) * Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before surgery * Bleeding disorder or abnormal preoperative coagulation profile (as identified by a preoperative platelet count of \<100,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \>1.4 times normal) * Preexisting anemia \<10 g/dL * Color blindness or disturbance of color vision * Leukemia or active cancer * Religious restrictions on blood transfusion * Pregnancy or women who are lactating/breastfeeding

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Simple blinded randomization will occur by the pharmacy prior to distribution of the intervention drug.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-04-08