Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty

January 18, 2017 updated by: Nicoleta Stoicea, Ohio State University
The purpose of this study is to determine the need for a blood transfusion during surgery and to evaluate the levels of certain proteins in the blood when given tranexamic acid.

Study Overview

Status

Completed

Conditions

Detailed Description

A review of the medical record between January 01 2013 to July 1st 2015 will be used to determine if the hypothesis that patients receiving tranexamic acid will have a lower need for blood transfusion and there are changes in the levels of the proteins essential for healthy oxygen transport throughout the body is correct. Tranexamic acid is a medication which may help wounds to stop bleeding more quickly. Participants are not expected to receive any direct benefits from participating in this study. Only a small risk of private patient medical information being exposed is anticipated. The results of this study will help surgeons and the medical community to better understand the uses of this type of drug and its possible role in benefiting hip replacement patients during and following surgery.

Study Type

Observational

Enrollment (Actual)

576

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
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Four surgeons providing total hip replacement services within the date range for data collection have formally agreed to include their patients in the study population, therefore identification of patients will occur through screening the surgery log of each surgeon performing these surgeries within the defined date range.

Description

Inclusion Criteria:

  • Adult patients 18 years of age and older
  • Surgical patients who underwent primary total hip arthroplasty (THA)
  • Surgical patients who underwent revision THA
  • Preoperative hemoglobin values (N) 11 g/dl
  • Normal international normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT) values

Exclusion Criteria:

  • - Allergy to tranexamic acid
  • Bilateral THA
  • History of ischemic heart disease
  • Severe chronic heart failure
  • Hepatic dysfunction
  • Chronic renal failure
  • On hemodialysis
  • Cerebral infarction
  • History of seizure
  • Bleeding disorder
  • Anticoagulant or aspirin-like medication and long acting NSAID medication
  • Short acting NSAID's were discontinued at least 24 hrs before surgery

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin, hematocrit, and red blood cell transfusion rates
Time Frame: Peri-operative care
Whether intraoperative dose of 2gr tranexamic acid (TXA) in patients having primary or revision THA would decrease the perioperative and post-operative reduction in hemoglobin, hematocrit, and red blood cell transfusion rates compared with those of a similar group of patients who did not receive TXA (control group).
Peri-operative care

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinically-significant venous thromboembolism (VTE) and all-cause mortality
Time Frame: within 30 days of surgery
frequency of clinically-significant venous thromboembolism (VTE) and all-cause mortality within 30 days of surgery
within 30 days of surgery

Collaborators and Investigators

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

Sponsor

Ohio State University

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

January 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimate)

December 12, 2016

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015H0427

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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