TXA in Spinal Fusion

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, and duration of hospital stay will be collected.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Zanaty
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Age 18-80 years

2. American Spinal Injury Association (ASIA) Impairment Scale anesthesia risk of I to IV

3. Body Mass Index (BMI) of<35

4. Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.

5. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.

Exclusion Criteria:

1. ASIA class V

2. Patient unable to consent

3. Patient with chronic kidney disease stage III or above: baseline plasma creatinine>1.5mg/dL

4. Patient with known liver failure

5. Patients on anticoagulation or dual antiplatelets (presence of vascular stents).

6. Patients with artificial valves.

7. Patients with allergy to TXA

8. Patients with platelet count < 150 000,

9. Patients with PT<60%

10. Patients with Activated Partial Thromboplastin Time (APPT) >38s

11. History of stroke or (an) unprovoked thromboembolic event(s).

12. History of intracranial bleeding,

13. Pregnancy

14. known defective color vision

15. history of venous or arterial thromboembolism or active thromboembolic disease

16. Patients with severe pulmonary or cardiac disease.

17. Patients who refuse transfusion of blood products

18. Patients with chronic anemia with Hg<8

19. Patients undergoing lumbar fusion for disease other than DDD (neoplasm)

20. Patients undergoing lumbar fusion by anterior or lateral approach.

21. Minimally invasive TLIF are excluded.

22. Emergent cases.