TXA in Spinal Fusion

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04272606
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Catherine R. Olinger
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Catherine Olinger, M.D.
Principal Investigator Affiliation	University of Iowa
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Degenerative Disc Disease

Additional Details

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 incidence and severity will be assessed daily for the first 5 days after surgery and at discharge. 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.

Arms & Interventions

Arms

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

Interventions

Drug: - Tranexamic Acid

Antifibrinolytic Agent

Drug: - Saline Solution

Placebo

Diagnostic Test: - Visual Acuity Exam

Supplemented into standard of care daily neurological exam on day of surgery and day after

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

3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Site Contact

Sarah Lee

[email protected]

951-425-7651

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