TXA in Spinal Fusion

Catherine R. Olinger

Status and phase: Completed; Phase 2

Conditions: Degenerative Disc Disease

Treatments: Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM); Drug: Saline Solution; Diagnostic Test: Visual Acuity Exam; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04272606

201912099

Details and patient eligibility

About

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, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.

Full description

This study is to assess whether tranexamic acid (a drug that is used to coagulate the blood and reduce bleeding) use in lumbar spinal fusion can reduce blood loss and postoperative delirium compared to placebo. Thusly reducing need for transfusion, shorting the hospital stay and improving outcomes. For this the study will randomize patients who are receiving elective lumbar interbody fusion (PLIF or TLIF) of 2 or more levels for degenerative disc disease (DDD) into 2 groups. Group 1 would receive tranexamic acid during the surgery while group 2 will receive placebo. Blood loss during the surgery and postoperatively (while the patient has a drain) will be monitored along with the amount of transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation, and and the duration of hospital stay. Delirium occurrence and severity will be assessed daily for the first 5 days after surgery or at discharge, whichever comes first. Cognitive status (neuropsychological tests) will be assessed at post-discharge follow up visits and compared to preoperative status.

The drug or placebo are only given during the surgery. The patient population includes elective cases of patient undergoing lumbar spinal fusion of 2 or more levels. Spinal fusions are known to be associated with blood loss, especially when the surgeries are long and more levels need to be fused.

Enrollment: 123 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

1:1 randomization, given tranexamic acid during surgery, visual acuity exam

Treatment:

Drug: Tranexamic Acid

Diagnostic Test: Visual Acuity Exam

Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

Placebo

Placebo Comparator group

Description:

1:1 randomization, given standard of care treatment during surgery, visual acuity exam

Treatment:

Diagnostic Test: Visual Acuity Exam

Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

Drug: Saline Solution