Tranexamic Acid Study

This study has been withdrawn prior to enrollment.
(Study halted prematurely as investigator left the institution.)
Sponsor:
Information provided by:
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00375440
First received: September 11, 2006
Last updated: May 25, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to determine if tranexamic acid significantly reduces blood loss and blood transfusion in revision total hip replacement. Tranexamic acid is a drug that helps to reduce blood loss during surgery. Revision total hip replacement surgery is treatment for patients who have previously had hipe replacement surgery which failed and must be repaired/replaced.


Condition Intervention
Arthroplasty, Replacement, Hip
Drug: Tranexamic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Placebo Controlled Study Using Tranexamic Acid in Revision Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Introperative blood loss
  • Total blood loss
  • Number of blood transfusions required

Secondary Outcome Measures:
  • Length of acute hospital stay

Estimated Enrollment: 36
Study Start Date: February 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Tranexamic acid is an anti-fibrinolytic agent that inhibits fibrinolysis leading to a reduction of blood loss without concurrently increasing the risk of thromboembolic complications. Several studies have shown that tranexamic acid reduces blood loss and blood transfusions in primary total hip and knee arthroplasty. However, there have not been any studies that evaluate its efficacy in revision total hip arthroplasty. The significance of this study is that the need for blood transfusions and their complications may be minimized in revision hip arthroplasty if tranexamic acid is found to significantly decrease the amount of blood transfusions.

After the patient has been consented, he or she will be randomized into one of two groups (tranexamic acid and placebo) by the School of Pharmacy. The placebo will be crystalloid fluid of equal volume as tranexamic acid. The patient will then undergo revision total hip arthroplasty by Dr. Rosenstein and be administered tranexamic acid or placebo. Blood loss will be recorded intraoperatively and postoperatively through drains. Criteria for blood transfusion include hemoglobin less than 10g/dl or hematocrit less than 30%. Once the operation ends, the drug or placebo will be discontinued and the postoperative care is unchanged from current standards/protocols. Intraoperative blood loss, total blood loss, and number of blood transfusions will be recorded and analyzed. Length of acute hospital stay will also be recorded. A cost analysis will be performed comparing tranexamic acid to blood transfusions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Failed primary total hip arthroplasty (femoral stem, acetabular component, or both)
  • 18-100 years of age

Exclusion Criteria:

  • Prosthetic infection
  • Primary total hip arthroplasty
  • Prisoners
  • Pregnancy
  • Previous adverse reaction to tranexamic acid
  • Bleeding/coagulation disorders
  • Renal insufficiency (serum creatinine>two standard deviations for age)
  • History of deep venous thrombosis or pulmonary embolism
  • Religious beliefs/practices prohibiting blood transfusions
  • Wards of the state
  • Cognitively impaired patients
  • Terminally ill patients
  • Students and/or employees
  • Color blindness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375440

Locations
United States, Texas
Texas Tech University Health Sciences Center Department of Orthopaedic Surgery
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Alexander D Rosenstein, MD Texas Tech University Health Sciences Center Department of Orthopaedic Surgery
  More Information

Publications:

Responsible Party: Alexander Rosenstein, MD
ClinicalTrials.gov Identifier: NCT00375440     History of Changes
Other Study ID Numbers: L05-063
Study First Received: September 11, 2006
Last Updated: May 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Tranexamic Acid
Revision Total Hip Replacement
Reduction in Blood Loss

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014