Using Tranexamic Acid to Reduce Blood Loss in Spinal Surgery

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

This study is testing if using tranexamic acid in different ways can help adults having spinal surgery lose less blood and recover faster.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hospital for Special Surgery, New York (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT03553186 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of tranexamic acid (TXA) in reducing blood loss during posterior spinal surgery for adult deformities. The study compares the use of intravenous TXA with topical TXA to determine if the combination can further decrease perioperative blood loss, transfusion requirements, and length of hospital stay. Participants will be adults scheduled for extensive spinal fusion surgery, and the trial aims to provide insights into the safety and efficacy of this treatment approach. The study is being conducted at the Hospital for Special Surgery in New York.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 scheduled for posterior spinal fusion surgery involving five or more levels.

Not a fit: Patients with renal or hepatic insufficiency, history of thromboembolic events, or those on certain anticoagulant therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce blood loss and improve recovery outcomes for patients undergoing spinal deformity surgery.

How similar studies have performed: Previous studies have shown success with TXA in other surgical fields, but this specific application in spinal deformity surgery is novel.

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

Where this trial is running

New York, New York

• Hospital for Special Surgery — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Han Jo Kim, MD — Department of Spine Surgery
• Study coordinator: Jordan A Gruskay, MD

Conditions Spinal Deformity; Degenerative Lumbar Spinal Stenosis; Blood Loss, Surgical