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Blood Loss After Early TXA in Hip Fractures.

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ClinicalTrials.gov Identifier: NCT04488367
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Michael Allen, Community Memorial Health System

Brief Summary:
Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.

Condition or disease Intervention/treatment Phase
Hip Fractures Drug: Tranexamic acid Drug: Normal Saline Early Phase 1

Detailed Description:

Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation.

Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.
Actual Study Start Date : July 6, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early TXA
Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.
Drug: Tranexamic acid
10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU
Other Name: Early TXA

Control
Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.
Drug: Normal Saline
100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU
Other Name: Control Placebo




Primary Outcome Measures :
  1. Change in calculated and recorded hemoglobin [ Time Frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. ]
    Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.

  2. Total postoperative units of red blood cell transfusion [ Time Frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. ]
    The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.


Secondary Outcome Measures :
  1. VTE [ Time Frame: Postoperative for 30 days ]
    DVT or PE

  2. Infection [ Time Frame: Postoperative for 30 days ]
    Superficial and deep infections

  3. Readmission [ Time Frame: Within 30 days postoperative ]
    30 day readmission

  4. Other complications [ Time Frame: Postoperative for 30 days ]
    Any additional unforeseen complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Femoral neck, intertrochanteric, subtrochanteric femur fracture
  • Age >18
  • Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon

Exclusion Criteria:

  • Age <18
  • Concomitant fracture
  • Preoperative anemia needing blood transfusion before surgery
  • Severe comorbidity (active cancer, severe pulmonary disease, ESRD)
  • Allergy for tranexamic acid
  • History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months
  • Myocardial infarction in the previous 12 months
  • Renal function impairment (creatinine clearance <30 mL/min), or kidney transplant
  • History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488367


Contacts
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Contact: Michael Allen, DO 805-948-5100 mallen@cmhshealth.org

Locations
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United States, California
Community Memorial Hospital Recruiting
Ventura, California, United States, 93003
Contact: Michael Allen    805-948-5100    mallen@cmhshealth.org   
Sponsors and Collaborators
Community Memorial Health System
Investigators
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Principal Investigator: Michael Allen, DO Resident physician
Publications:

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Responsible Party: Michael Allen, Principal Investigator, Community Memorial Health System
ClinicalTrials.gov Identifier: NCT04488367    
Other Study ID Numbers: TXARCT1
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Allen, Community Memorial Health System:
tranexamic acid
TXA
hip fracture
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants