TXA in Spinal Fusion

Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Drug: Tranexamic Acid; Diagnostic test: Visual Acuity Exam; Drug: Saline Solution; Diagnostic test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sarah Lee; Phone Number: (951)425-7651; Email: sarah-j-lee@uiowa.edu
• Study Contact Backup: Name: Catherine Olinger, M.D.; Phone Number: (319) 384-5892; Email: catherine-olinger@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; 1:1 randomization, given tranexamic acid during surgery, visual acuity exam	Drug: Tranexamic Acid; Antifibrinolytic Agent; Other Names: Cyklokapron; Diagnostic test: Visual Acuity Exam; Supplemented into standard of care daily neurological exam on day of surgery and day after; Other Names: Eye Exam; 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.
Placebo Comparator: Placebo; 1:1 randomization, given standard of care treatment during surgery, visual acuity exam	Diagnostic test: Visual Acuity Exam; Supplemented into standard of care daily neurological exam on day of surgery and day after; Other Names: Eye Exam; Drug: Saline Solution; Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion	Amount of red blood cells (RBC) transfused intraoperatively and up to 7 days post-operatively	Up to 7 days or until discharge
Blood Loss	Amount of blood loss intraoperatively and up to 7 days post-operatively	Up to 7 days or until discharge
Delirium	Delirium incidence (yes/no) and severity (score 0-20) using daily 3D-CAM delirium assessment instrument.	up to 7 days or until discharge

Collaborators and Investigators

• Sponsor: Catherine R. Olinger
• Investigators: Principal Investigator: Catherine Olinger, M.D., University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Neurosurgery; Delirium; Tranexamic Acid; Posterior Lumbar Interbody Fusion; Transforaminal Lumbar Interbody Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 201912099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No