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TXA in Spinal Fusion

NCT ID: NCT04272606

Last Updated: 2024-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-06-12

Brief Summary

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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

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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.

Conditions

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Degenerative Disc Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

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

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Antifibrinolytic Agent

Visual Acuity Exam

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

Placebo

Visual Acuity Exam

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Tranexamic Acid

Antifibrinolytic Agent

Intervention Type DRUG

Saline Solution

Placebo

Intervention Type DRUG

Visual Acuity Exam

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Cyklokapron Eye Exam

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catherine R. Olinger

OTHER

Sponsor Role lead

Responsible Party

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Catherine R. Olinger

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Catherine Olinger, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40276619 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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201912099

Identifier Type: -

Identifier Source: org_study_id