Tranexamic Acid in Adult Spinal Deformity Surgery
Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery
Hospital for Special Surgery, New York
100 participants
Jul 11, 2018
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria19
- 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
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Interventions
TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction.
Placebo solution (200 cc sterile normal saline + placebo TXA ampule (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction.
Locations(1)
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NCT03553186