Blood Loss After Early TXA in Hip Fractures.

July 18, 2022 updated by: Michael Allen, Community Memorial Health System

The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Recruiting
        • Community Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • Early TXA
OTHER: 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 Names:
  • Control Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
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.
From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VTE
Time Frame: Postoperative for 30 days
DVT or PE
Postoperative for 30 days
Infection
Time Frame: Postoperative for 30 days
Superficial and deep infections
Postoperative for 30 days
Readmission
Time Frame: Within 30 days postoperative
30 day readmission
Within 30 days postoperative
Other complications
Time Frame: Postoperative for 30 days
Any additional unforeseen complications
Postoperative for 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Community Memorial Health System

Investigators

  • Principal Investigator: Michael Allen, DO, Resident Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2020

Primary Completion (ANTICIPATED)

July 1, 2023

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (ACTUAL)

July 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXARCT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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