Efficacy of Tranexamic Acid (TXA) in Humerus ORIF (TXA)

December 10, 2024 updated by: Peter Tang, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design to determine if TXA aids in prevention of blood loss in upper extremity trauma, specifically humerus fractures. Patient population includes male and female adults with no history of thromboses who suffered an isolated humeral injury. Patients will be evaluated at Allegheny General Hospital (AGH) as surgical candidates and allocated to the exposure group (receive TXA) or the control group (saline placebo). Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery. The control group will have saline administered 10 minutes prior to surgery. Patients will be seen in follow up at both 2 weeks and 6 weeks postoperatively, as well as followed through the electronic medical record (EMR).

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network Allegheny General Hospital

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males or females age 18-100 years
  2. Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation.
  3. Must be able to read and understand English and consent for themselves.

Exclusion Criteria:

  1. Allergy to TXA.
  2. Acquired disturbances of color vision.
  3. History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA.
  4. Pregnant or breastfeeding.
  5. Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement.
  6. Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men)
  7. Refusal of blood products
  8. Subarachnoid hemorrhage
  9. Disseminated intravascular coagulation

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery
Drug: Tranexamic acid (TXA)
1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery
Other Names:
  • Tranexamic acid
Placebo Comparator: Control Group
The control group will have saline administered 10 minutes prior to surgery.
Other: Saline
control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Intraoperatively
The estimated total blood loss measured intraoperatively. This will be done by estimating absorbed drainage by surgical gauze and adding this to total volume in suction canister. Total volume of irrigation used will be subtracted from this total to give an estimate of intraoperative blood loss.
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: From the start of surgical procedure through the completion of the surgical procedure
Amount of time of operative procedure
From the start of surgical procedure through the completion of the surgical procedure
Duration of follow-up
Time Frame: Through study completion, an average of one year.
Through study completion, an average of one year.
Through study completion, an average of one year.
Complications (DVT, PE, stroke)
Time Frame: through study completion, an average of one year
Presence or absence of the monitored complications (DVT, PE, stroke) will be recorded as a categorical data value.
through study completion, an average of one year

Collaborators and Investigators

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

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Investigators

  • Principal Investigator: Peter Tang, MD, Allegheny Health Network Allegheny General Hospital

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)

April 12, 2023

Primary Completion (Actual)

November 25, 2024

Study Completion (Actual)

November 25, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-153

Drug and device information, study documents

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

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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