Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery
Hospital for Special Surgery, New York
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.
Description
Blood loss is a significant issue in spinal deformity surgery, often requiring allogenic blood transfusion and/or intraoperative blood salvage and leading to increased risk of postoperative morbidity, increased length of stay, and higher total hospital costs. Tranexamic acid is an antifibrinolytic agent that is used in many surgical specialties to prevent perioperative blood loss. Intravenous (ivTXA) dosing has proven effective in reducing blood loss and perioperative transfusion in spinal surgery, while the topical (tTXA) form has been shown to be at least non-inferior to IV transfusion in th…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 disor…
Interventions
- DrugTranexamic Acid 100 MG/ML
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.
- DrugPlacebo
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.
Location
- Hospital for Special SurgeryNew York, New York