Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT04272606
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-90 years
2. American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV
3. Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
4. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.
Exclusion Criteria:
1. ASA 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\>15s
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.
23. Women on hormonal contraception
24. Retinal vein or artery occlusion
25. Hypercoagulability
26. Seizure disorder
27. Current use of tretinoin
28. Current use of chlorpromazine
29. Breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04272606
Study Brief:
Protocol Section:
NCT04272606