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TXA in Spinal Fusion

Sponsor
Royce W. Woodroffe, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT04272606
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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, and duration of hospital stay will be collected.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid
  • Drug: Saline Solution
  • Diagnostic Test: Visual Acuity Exam
 Phase 2

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 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 and the duration of hospital stay.

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomizationPhase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Clinical Trial for Tranexamic Acid (TXA) in Lumbar Interbody Spinal Fusion
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

    		•
    Placebo Comparator: Placebo

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

    Drug: Saline Solution
    Placebo

    Diagnostic Test: Visual Acuity Exam
    Supplemented into standard of care daily neurological exam on day of surgery and day after
    Other Names:
  • Eye Exam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Transfusion [Up to 7 days]

      Amount (in cells cubed) of red blood cells (RBC) transfused intraoperatively and up to 7 days post-operatively

    2. Blood Loss [Up to 7 days]

      Amount (in cells cubed) of blood loss intraoperatively and up to 7 days post-operatively

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 18-90 years

    2. American Spinal Injury Association (ASIA) Impairment Scale anesthesia risk of I to IV

    3. Body Mass Index (BMI) of<35

    4. Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.

    5. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.

    Exclusion Criteria:

    1. ASIA 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<60%

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Royce W. Woodroffe, MD

    Investigators

    • Principal Investigator: Royce Woodroffe, M.D., University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royce W. Woodroffe, MD, Principal Investigator, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT04272606
    Other Study ID Numbers:
    • 201912099
    First Posted:
    Feb 17, 2020
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Royce W. Woodroffe, MD, Principal Investigator, University of Iowa
    Posterior Lumbar Interbody Fusion
    Transforaminal Lumbar Interbody Fusion
    Tranexamic Acid
    Neurosurgery
    Additional relevant MeSH terms:
    Intervertebral Disc Degeneration
    Tranexamic Acid

    Study Results

    No Results Posted as of Mar 23, 2022