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.
Full Title of Study: “Randomized Clinical Trial for Tranexamic Acid (TXA) in Lumbar Interbody Spinal Fusion”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: April 2022
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 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 and the duration of hospital stay.
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.
- Drug: Tranexamic Acid
- Antifibrinolytic Agent
- Drug: Saline Solution
- Diagnostic Test: Visual Acuity Exam
- Supplemented into standard of care daily neurological exam on day of surgery and day after
Arms, Groups and Cohorts
- Active Comparator: Treatment
- 1:1 randomization, given tranexamic acid during surgery, visual acuity exam
- Placebo Comparator: Placebo
- 1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Clinical Trial Outcome Measures
- Time Frame: Up to 7 days
- Amount (in cells cubed) of red blood cells (RBC) transfused intraoperatively and up to 7 days post-operatively
- Blood Loss
- Time Frame: Up to 7 days
- Amount (in cells cubed) of blood loss intraoperatively and up to 7 days post-operatively
Participating in This Clinical Trial
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.
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,
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Mario Zanaty
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Mario Zanaty, Principal Investigator – University of Iowa
- Overall Official(s)
- Mario Zanaty, M.D>, Principal Investigator, University of Iowa
- Overall Contact(s)
- Eleanor C Ryan, 319-467-5677, email@example.com
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