TXA in Spinal Fusion

Catherine R. Olinger123 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

123

Conditions

Degenerative Disc Disease

Interventions

Tranexamic AcidDRUG

Antifibrinolytic Agent

Saline SolutionDRUG

Placebo

Visual Acuity ExamDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Transfusion

The number of participants who had red blood cells (RBC) transfused: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively

Time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Blood Loss

Amount of blood loss: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively

Time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Delirium Occurrence

Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.

Time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Secondary Outcomes

Delirium Severity

Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium)

Time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported

Change in Interleukin-6 Concentration.

Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw.

Time frame: Preoperatively and 24 hours postoperatively

Length of Postoperative Stay Prior to Discharge

Length of postoperative stay prior to discharge in days

Time frame: Days thru day of discharge

Data from ClinicalTrials.gov

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