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โ† Trials
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Tranexamic Acid in Adult Spinal Deformity Surgery

RecruitingPhase 3Ages 18 Years - 80 YearsAllHospital for Special Surgery, New York
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18-80 * Scheduled to undergo posterior long segment ( โ‰ฅ 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
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What it tests

  • Tranexamic Acid 100 MG/ML
  • Placebo
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Where

1 site
Hospital for Special Surgery
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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