Using Tranexamic Acid to Reduce Blood Loss in Spinal Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: gruskayj@hss.edu
• Phone: 2034647759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.