The Effect of Tranexamic Acid for Total Hip Arthroplasty

March 24, 2014 updated by: seher orbay yasli, TC Erciyes University

The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty

The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

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 Contact Backup

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Recruiting
        • Erciyes univercity medicine faculty
        • 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 2-3
  • 18-75 age
  • total hip arthroplasty surgery
  • regional anesthesia

Exclusion Criteria:

  • allergies to drug
  • liver and kidney failure
  • ischemic heart disease
  • coagulopathy

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tranexamic acid
preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
Drug: tranexamic acid
preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
Other Names:
  • lysteda
Sham Comparator: serum physiologic
preoperative 100 cc serum physiologic
Drug: serum physiologic
preoperative 100 cc ıv serum physiologic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemorrhage
Time Frame: intraoperative
the amount of bleeding in aspirator and sponges
intraoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
erythrocyte transfusion
Time Frame: intraoperative and postoperative 3 days
intraoperative and postoperative 3 days

Collaborators and Investigators

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

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: seher orbay yasli, resident, Erciyes university medicine faculty

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

March 1, 2014

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/683

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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