Using tranexamic acid to reduce blood loss in spine surgery

Topical Application of Tranexamic Acid (CYKLOKAPRON®) to Reduce Blood Loss During Spine Surgery

This study is testing if using tranexamic acid during spine surgery can help reduce blood loss and the need for blood transfusions in patients having posterior spinal fusion.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Columbia University (Academic / other)
• Drugs / interventions: radiation
• Locations: 4 sites (San Francisco, California and 3 other locations)
• Trial ID: NCT02314988 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of topical tranexamic acid in reducing perioperative blood loss during spine surgeries, particularly for patients undergoing posterior spinal fusion. It is a prospective, randomized, double-blind, placebo-controlled trial involving two groups: one receiving tranexamic acid and the other receiving a placebo. The study aims to determine if this intervention can lower postoperative drain output and the need for blood transfusions, thereby potentially decreasing the risk of surgical site infections. Participants will be followed for two years to assess outcomes related to blood loss and transfusion requirements.

Who should consider this trial

Good fit: Ideal candidates include adults with thoracic or lumbar spinal injuries requiring surgical fixation within 21 days of injury.

Not a fit: Patients with severe soft tissue disruption, ongoing infections, or those who are allergic to tranexamic acid may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce blood loss and the need for transfusions in patients undergoing complex spine surgeries.

How similar studies have performed: Previous studies in other surgical fields have shown success with tranexamic acid, suggesting a promising potential for this approach in spine surgery.

Eligibility criteria

Inclusion Criteria:

1. Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
2. Surgical fixation to be performed within 21 days of injury
3. Adult patients undergoing long segment (\>5 fusion levels) posterior spinal fusions

Exclusion Criteria:

1. Age \<18 or \>80 years old
2. Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure
3. Physiologic instability or ongoing sepsis/infection
4. Use of intravenous tranexamic acid during the pre-study period
5. Ballistic spinal column injury
6. Allergy to tranexamic acid
7. Disturbances of color vision or color blindness
8. Pre-operative hemoglobin value of \<7 g/dL, or \<10 g/dL if patient has comorbidities or symptoms which will require pre-operative allogeneic blood transfusion
9. Refusal to consent for blood products
10. Participation in another clinical trial
11. Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys
12. Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA
13. Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased
14. Preoperative use of anticoagulant therapy (heparin, low-molecular weight heparin, warfarin) within three days before surgery, or non-steroid inflammatory medication (aspirin, ibuprofen, naprosyn) use within seven days before surgery
15. Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment
16. Disseminated intravascular coagulation (DIC)
17. Coagulopathy (as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \>1.4 times normal)
18. History of arterial or venous thromboembolic disease (such as a cerebrovascular accident, deep-vein thrombosis, or pulmonary embolus), as these patients may be at increased risk for venous or arterial thrombosis
19. Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported)
20. Pregnancy or breastfeeding (Category B)
21. Substantial renal dysfunction (as assessed by a serum creatinine \> 1.5 or calculated creatinine clearance of \< 50) or hepatic failure
22. Major co-morbidities: alcohol or drug abuse, illnesses that affect bone or calcium metabolism, connective tissue disorders, coronary artery disease, severe ischemic heart disease \[New York Heart Association Class III or IV\], previous myocardial infarction, severe pulmonary disease \[forced expiratory volume \<50% of normal\], diabetes mellitus (Type I or Type II), immunosuppression, peripheral vascular disease, severe penetrating or hemorrhagic traumatic brain injury, a history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton.
23. History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold
24. History of dural tear or open subdural space

Where this trial is running

San Francisco, California and 3 other locations

• University of California San Francisco Medical Center — San Francisco, California, United States (Recruiting)
• Norton Leatherman Spine Center — Louisville, Kentucky, United States (Recruiting)
• NYP/The Allen Hospital - CUIMC — New York, New York, United States (Recruiting)
• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Ronald A Lehman, MD — Columbia University
• Study coordinator: Ronald A Lehman, MD

Conditions Spinal Injuries; Spinal Deformity; Tranexamic acid; Antifibrinolytic; Perioperative blood loss; Postoperative drain output; Allogenic transfusion