Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit

May 17, 2023 updated by: Michael Archdeacon, University of Cincinnati

The Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin / Hematocrit in Isolated Operative Posterior Wall Acetabular Fractures: a Prospective, Randomized, Double-blinded, Multicenter Study

This multi-center, prospective study will evaluate the use of topical tranexamic acid (TXA - Cyklokapron; Pfizer, New York, NY) on pre-operative and post-operative hemoglobin (Hb)/hematocrit (Hct) in patients undergoing operative repair of isolated posterior wall (PW) acetabular fractures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this prospective, randomized, double-blinded, multi-center study comparing topical TXA with placebo, investigators will determine whether topical TXA utilization in isolated PW acetabular surgery has beneficial or detrimental effects.

In order to evaluate the delta between pre-operative and post-operative hemoglobin (blood loss parameters) in patients with isolated PW acetabular fractures that were treated with topical TXA or a placebo, investigators will prospectively enroll all eligible patients with the diagnosis of a closed, isolated, PW acetabular fracture that requires surgical fixation. Isolated PW fractures have been chosen to reduce confounding variables, particularly those associated with more complex fracture patterns including longer surgery duration and blood loss.

Each subject will have a pre-operative Hb and Hct drawn on the morning of surgery to establish a baseline level. Prior to surgery, subjects will be computer-randomized by pharmacy to one of two groups: a topical TXA group and a control group. The topical TXA group will be treated with 2 gm/100 ml of normal saline, while the control group will be treated with a placebo (normal saline) in a similar fashion to the TXA experimental group.

The surgeon and the operative team will be blinded as to whether the patient receives TXA or placebo.

Intraoperative transfusion requirements and estimated blood loss (EBL) will be recorded for every patient.

Hemoglobin and hematocrit values will be obtained on postoperative day one and two with routine morning blood draws (typically 5 am-9 am). Post-operative transfusion requirements prior to discharge will be recorded. All patients will have standard low molecular weight heparin DVT prophylaxis for four weeks post-operatively.

Prospectively demographic data will be collected. Injury and treatment data collected will include date of injury, mechanism of injury, laterality of injury, medical co-morbidities, associated injuries, date of surgery, operative time, estimated operative blood loss (EBL) from both anesthesia and operative surgeon, calculated operative blood loss, as well as hemoglobin/hematocrit as described, and blood transfusions.

Study Type

Interventional

Enrollment (Anticipated)

98

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
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati College of Medicine
        • Contact:
        • 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

No

Description

Inclusion Criteria:

  1. Patients with an isolated, closed, posterior wall acetabular fracture managed surgically within 7 days of injury. Upper extremity fractures that are non-operative and have no impact on weight-bearing status will be included.
  2. Patients must be skeletally mature.

Exclusion Criteria:

  1. Patients are not skeletally mature.
  2. Patients with any concomitant lower extremity, pelvis, or spine injuries.
  3. Patient admitted as a polytrauma patient to the trauma service due to injury to an internal organ (head, chest, or abdomen).
  4. Patient has an unidentified source of hemorrhage other than acetabular fracture.
  5. Patient requires surgery for treatment of concomitant injuries.
  6. Patient requires multiple surgeries.
  7. Patient has pre-existing thrombus prior to surgery.
  8. Patient with a history of prior pulmonary embolus or other thromboembolic disease.
  9. Patient with a known bleeding disorder.
  10. Patient with a history of renal insufficiency.
  11. Patient who is unable to give consent or is unconscious.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical TXA Treatment
2 gm TXA/100 ml of normal saline
Drug: Tranexamic Acid
Topical application
Other Names:
  • Cyklokapron, Pfizer
Placebo Comparator: No Topical Treatment
Normal saline
Drug: Normal saline
Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin (Hb)
Time Frame: Postoperative Day 2
Hemoglobin (Hb) results
Postoperative Day 2
Hematocrit (Hct)
Time Frame: Postoperative Day 2
Hematocrit (Hct) results
Postoperative Day 2

Collaborators and Investigators

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

Sponsor

University of Cincinnati

Collaborators

Foundation for Orthopedic Trauma

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)

August 25, 2017

Primary Completion (Anticipated)

August 30, 2025

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 2016-2519

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

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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