Clinical trial NCT04272606: TXA in Spinal Fusion
Official title: Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Degenerative Disc Disease
Keywords: Posterior Lumbar Interbody Fusion
Transforaminal Lumbar Interbody Fusion
Tranexamic Acid
Neurosurgery
Delirium
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization
Primary purpose: TREATMENT

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

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 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.

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

Primary outcomes:
measure: Transfusion
timeFrame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
measure: Blood Loss
timeFrame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
measure: Delirium Occurrence
timeFrame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Secondary outcomes:
measure: Delirium Severity
timeFrame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
measure: Change in Interleukin-6 Concentration.
timeFrame: Preoperatively and 24 hours postoperatively
measure: Length of Postoperative Stay Prior to Discharge
timeFrame: Days thru day of discharge
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Catherine Olinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References: