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The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

Primary Purpose

Blood Loss Following Open Femur Fracture Surgery

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic acid (TXA)
Normal saline
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss Following Open Femur Fracture Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.

Exclusion Criteria:

  • Preoperative use of any anticoagulant
  • History of deep venous thrombosis or pulmonary embolus
  • Allergy to TXA
  • Hepatic dysfunction (AST/ALT > 60)
  • Renal dysfunction (Cr > 1.5 or GFR < 30)
  • History of cerebrovascular accident in the past 12 months
  • Active coronary artery disease (event in the past 12 months)
  • Presence of drug-eluting stent
  • Color blindness
  • Presence of an additional acute injury that could contribute to blood transfusion requirements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tranexamic acid (TXA)

    Normal saline

    Arm Description

    Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.

    Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

    Outcomes

    Primary Outcome Measures

    Transfusion requirements as assessed by number of packed red blood cell units received

    Secondary Outcome Measures

    Surgical blood loss as assessed by change in red blood cell volume
    Blood loss will be determined using the following calculations: [Patient's Blood Volume (PBV) = (k1 x Height^3 (m)) + (k2 x Weight (kg)) + k3] (- k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men) (- k1 = 0.3561, k2=0.03308, and k3 = 0.1833 for women) Multiplying the PBV by the hematocrit (Hct) gives the red blood cell (RBC) volume. As such, a change in the RBC volume can be calculated from a change in the Hct level as follows. PACU is post-anesthesia care unit: [Operative RBC volume loss = PBV x (Day of surgery Hct - PACU Hct)] If a patient requires an intraoperative transfusion, the calculation will be adjusted as follows: Operative RBC volume loss = [ [PBV x (Day of surgery Hct - PACU Hct)] +)] + (No. of Units Transfused x 0.285) / (Day of surgery Hct - Post-op Hct) / 2) ]
    Surgical blood loss as assessed by an intraoperative cell salvage machine
    The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss.
    Length of hospital stay
    Number of participants with complications
    Complications include infection, venous thromboembolic event, and mortality.

    Full Information

    First Posted
    July 24, 2018
    Last Updated
    October 14, 2019
    Sponsor
    The University of Texas Health Science Center, Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03679481
    Brief Title
    The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
    Official Title
    The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study not started due to lack of funding
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    April 1, 2021 (Anticipated)
    Study Completion Date
    April 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center, Houston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Loss Following Open Femur Fracture Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic acid (TXA)
    Arm Type
    Experimental
    Arm Description
    Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid (TXA)
    Intervention Description
    Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Intervention Description
    Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
    Primary Outcome Measure Information:
    Title
    Transfusion requirements as assessed by number of packed red blood cell units received
    Time Frame
    from the time of surgery to hospital discharge (about 3-5 days)
    Secondary Outcome Measure Information:
    Title
    Surgical blood loss as assessed by change in red blood cell volume
    Description
    Blood loss will be determined using the following calculations: [Patient's Blood Volume (PBV) = (k1 x Height^3 (m)) + (k2 x Weight (kg)) + k3] (- k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men) (- k1 = 0.3561, k2=0.03308, and k3 = 0.1833 for women) Multiplying the PBV by the hematocrit (Hct) gives the red blood cell (RBC) volume. As such, a change in the RBC volume can be calculated from a change in the Hct level as follows. PACU is post-anesthesia care unit: [Operative RBC volume loss = PBV x (Day of surgery Hct - PACU Hct)] If a patient requires an intraoperative transfusion, the calculation will be adjusted as follows: Operative RBC volume loss = [ [PBV x (Day of surgery Hct - PACU Hct)] +)] + (No. of Units Transfused x 0.285) / (Day of surgery Hct - Post-op Hct) / 2) ]
    Time Frame
    baseline, while in PACU (which is about 4-6 hours after surgery)
    Title
    Surgical blood loss as assessed by an intraoperative cell salvage machine
    Description
    The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss.
    Time Frame
    at the time of surgery
    Title
    Length of hospital stay
    Time Frame
    from the time of hospital admission to the time of hospital discharge (about 5 days)
    Title
    Number of participants with complications
    Description
    Complications include infection, venous thromboembolic event, and mortality.
    Time Frame
    6 weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures. Exclusion Criteria: Preoperative use of any anticoagulant History of deep venous thrombosis or pulmonary embolus Allergy to TXA Hepatic dysfunction (AST/ALT > 60) Renal dysfunction (Cr > 1.5 or GFR < 30) History of cerebrovascular accident in the past 12 months Active coronary artery disease (event in the past 12 months) Presence of drug-eluting stent Color blindness Presence of an additional acute injury that could contribute to blood transfusion requirements
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephen J Warner, MD, PhD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

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