Tranexamic Acid in Adult Spinal Deformity Surgery

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Jun 11, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called tranexamic acid (TXA) to help reduce blood loss during surgery for spinal deformities in adults. When patients undergo surgery for issues like scoliosis or degenerative spinal conditions, they often experience significant blood loss, which can lead to complications and the need for blood transfusions. The trial is specifically looking at whether using topical TXA in addition to intravenous TXA can further decrease blood loss and related problems during these surgeries.

To be eligible for this study, participants should be between 18 and 80 years old and scheduled for a specific type of spinal surgery that involves fusing at least five levels of the spine. However, certain conditions may exclude individuals from participating, including a history of blood clots, severe kidney or liver issues, or certain heart conditions. If you join the trial, you can expect to receive either the topical TXA, intravenous TXA, or a combination of both during your surgery, and the research team will monitor your recovery to see how it affects blood loss and your overall hospital stay. This study is currently recruiting participants, and it's an opportunity to contribute to new knowledge that could improve outcomes for future patients.

Gender

ALL

Eligibility criteria

• 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