Status:
COMPLETED
TXA in Spinal Fusion
Lead Sponsor:
Catherine R. Olinger
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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, pos...
Detailed 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 t...
Eligibility Criteria
Inclusion
- Age 18-90 years
- American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV
- Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
- Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.
Exclusion
- ASA class V
- Patient unable to consent
- Patient with chronic kidney disease stage III or above: baseline plasma creatinine\>1.5mg/dL
- Patient with known liver failure
- Patients on anticoagulation or dual antiplatelets (presence of vascular stents).
- Patients with artificial valves.
- Patients with allergy to TXA
- Patients with platelet count \< 150 000,
- Patients with PT\>15s
- Patients with Activated Partial Thromboplastin Time (APPT) \>38s
- History of stroke or (an) unprovoked thromboembolic event(s).
- History of intracranial bleeding,
- Pregnancy
- known defective color vision
- history of venous or arterial thromboembolism or active thromboembolic disease
- Patients with severe pulmonary or cardiac disease.
- Patients who refuse transfusion of blood products
- Patients with chronic anemia with Hg\<8
- Patients undergoing lumbar fusion for disease other than DDD (neoplasm)
- Patients undergoing lumbar fusion by anterior or lateral approach.
- Minimally invasive TLIF are excluded.
- Emergent cases.
- Women on hormonal contraception
- Retinal vein or artery occlusion
- Hypercoagulability
- Seizure disorder
- Current use of tretinoin
- Current use of chlorpromazine
- Breast feeding
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT04272606
Start Date
August 1 2020
End Date
June 12 2023
Last Update
December 12 2024
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242