TXA in Spinal Fusion

NCT04272606 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201912099
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease

Keywords

Posterior Lumbar Interbody Fusion; Transforaminal Lumbar Interbody Fusion; Tranexamic Acid; Neurosurgery; Delirium

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

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

Secondary Outcomes (3)

• Delirium Severity

  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.

  Preoperatively and 24 hours postoperatively

• Length of Postoperative Stay Prior to Discharge

  Days thru day of discharge

Study Arms (2)

Treatment

ACTIVE COMPARATOR

1:1 randomization, given tranexamic acid during surgery, visual acuity exam

Drug: Tranexamic Acid; Diagnostic Test: Visual Acuity Exam; Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

Placebo

PLACEBO COMPARATOR

1:1 randomization, given standard of care treatment during surgery, visual acuity exam

Drug: Saline Solution; Diagnostic Test: Visual Acuity Exam; Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

Interventions

Tranexamic Acid DRUG

Antifibrinolytic Agent

Also known as: Cyklokapron

Treatment

Saline Solution DRUG

Placebo

Placebo

Visual Acuity Exam DIAGNOSTIC_TEST

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

Also known as: Eye Exam

Placebo; Treatment

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

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

Placebo; Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catherine R. Olinger: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Hindman BJ, Olinger CR, Woodroffe RW, Zanaty M, Deifelt Streese C, Zacharias ZR, Houtman JCD, Wendt LH, Ten Eyck PP, O'Connell-Moore DJ, Ray EJ, Lee SJ, Waldschmidt DF, Havertape LG, Nguyen LB, Chen PF, Banks MI, Sanders RD, Howard MA 3rd. Exploratory randomised trial of tranexamic acid to decrease postoperative delirium in adults undergoing lumbar fusion-a trial stopped early. BJA Open. 2025 Apr 14;14:100403. doi: 10.1016/j.bjao.2025.100403. eCollection 2025 Jun.

  PMID: 40276619 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Delirium

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Catherine Olinger
• Organization: University of Iowa

catherine-olinger@uiowa.edu

319-384-5892

Study Officials

• Catherine Olinger, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: August 1, 2020
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: December 12, 2024
• Results First Posted: May 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)