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Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery

Primary Purpose

Blood Loss, Surgical, Blood Loss Anemia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
  • Must be able to swallow tablets

Exclusion Criteria

  • Known allergy to TXA
  • History of renal failure or kidney transplant
  • History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year
  • Placement of an arterial stent within the past year
  • History of blood clots (DVT, PE) within the past year
  • Refusal to receive blood products

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intravenous Tranexamic Acid

    Oral Tranexamic Acid

    Arm Description

    The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure.

    The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.

    Outcomes

    Primary Outcome Measures

    Intra-operative blood loss between the two groups
    For males: BV = 0.3669*(Height in meters)^3 + 0.03219*(Weight in kilograms) + 0.6041 For females: BV = 0.3561*(Height in meters)^3 + 0.03308*(Weight in kilograms) + 0.1833 Hbloss = BV*(Hbi-Hbe )*0.001 + Hbt Blood loss = 1000*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)

    Secondary Outcome Measures

    Post-operative drop in hemoglobin between the two groups
    Post-operative blood loss between the two groups
    Number of units transfused between the two groups
    Post-operative drain output between the two groups
    Incidence of thromboembolic events between the two groups

    Full Information

    First Posted
    January 23, 2017
    Last Updated
    January 27, 2017
    Sponsor
    Henry Ford Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03037515
    Brief Title
    Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
    Official Title
    A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 15, 2017 (Anticipated)
    Primary Completion Date
    August 15, 2017 (Anticipated)
    Study Completion Date
    November 16, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Henry Ford Health System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.
    Detailed Description
    Spine surgery is associated with large amount of perioperative blood loss. Factors influencing blood loss include surgical technique, operative time, number of vertebral levels arthrodesed, and others. Significant blood loss is associated with complications such as hypotension, end organ damage, or coagulopathy. Blood transfusions can increase risks of infection, blood incompatibility, and allergic reactions. Due to the significant risks and complications associated with blood loss and allogenic transfusions, efforts to identify safe and effective ways of lowering blood loss during spine surgery are crucial. Many methods have been utilized to reduce allogenic blood transfusions, such as autologous blood predonation, antifibrinolytic drugs, acute normovolemic hemodilution, intraoperative blood salvage, and others. Furthermore, the administration of antifibrinolytics, such as tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA), has been shown to reduce bleeding in cardiac, gynecological, urologic and total joint replacement surgeries. There have been many published studies investigating various antifibrinolytic agents such as TXA, EACA, and aprotinin. While aprotinin was shown to increase mortality rate in patients following cardiac surgery, TXA and EACA have not been shown to cause any substantial morbidity or to increase rate of thromboembolic events. Although IV TXA has been shown to be effective in reducing blood loss and transfusions in patients undergoing spine surgery, no studies in the literature have investigated the efficacy of PO TXA in decreasing blood loss and transfusions. The investigators believe that PO TXA will be just as efficacious and more cost-effective in reducing blood loss and transfusion needs in patients undergoing lumbar spine surgery. The ultimate goal is identifying the most cost-effective protocol to decrease blood loss and need for transfusion. If oral TXA is found to be as efficacious as IV TXA in reducing blood loss and need for transfusion, significant cost savings can be achieved for the patient and the health care system in general.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Loss, Surgical, Blood Loss Anemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous Tranexamic Acid
    Arm Type
    Active Comparator
    Arm Description
    The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure.
    Arm Title
    Oral Tranexamic Acid
    Arm Type
    Active Comparator
    Arm Description
    The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Other Intervention Name(s)
    Lysteda
    Intervention Description
    To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
    Primary Outcome Measure Information:
    Title
    Intra-operative blood loss between the two groups
    Description
    For males: BV = 0.3669*(Height in meters)^3 + 0.03219*(Weight in kilograms) + 0.6041 For females: BV = 0.3561*(Height in meters)^3 + 0.03308*(Weight in kilograms) + 0.1833 Hbloss = BV*(Hbi-Hbe )*0.001 + Hbt Blood loss = 1000*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)
    Time Frame
    Day of surgery to 1 day after surgery, up to 7 days
    Secondary Outcome Measure Information:
    Title
    Post-operative drop in hemoglobin between the two groups
    Time Frame
    1 day after surgery until patient is discharged, up to 7 days
    Title
    Post-operative blood loss between the two groups
    Time Frame
    1 day after surgery until patient is discharged, up to 7 days
    Title
    Number of units transfused between the two groups
    Time Frame
    1 day after surgery until patient is discharged, up to 7 days
    Title
    Post-operative drain output between the two groups
    Time Frame
    1 day after surgery until patient is discharged, up to 7 days
    Title
    Incidence of thromboembolic events between the two groups
    Time Frame
    1 day after surgery until patient returns for first postoperative visit (through study completion, an average of 4 weeks after surgery)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision) Must be able to swallow tablets Exclusion Criteria Known allergy to TXA History of renal failure or kidney transplant History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year Placement of an arterial stent within the past year History of blood clots (DVT, PE) within the past year Refusal to receive blood products
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charles C Yu, MD
    Phone
    314-614-3536
    Email
    cyu1@hfhs.org

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21936146
    Citation
    Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
    Results Reference
    background
    PubMed Identifier
    12697586
    Citation
    Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.
    Results Reference
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    Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery

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