Role of Topical Tranexamic Acid in Total Hip Arthroplasty (TXA)

February 13, 2018 updated by: Jose Rodriguez, MD, Northwell Health
Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

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
    • New York
      • New York, New York, United States, 10075
        • North Shore Long Island Jewish Lenox Hill 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 years of age.
  • Male or female.
  • Degenerative joint disease of hip joint.
  • Primary uncemented total hip arthroplasty.
  • Willingness to participate in the study, follow up at regular intervals

Exclusion Criteria:

  • Known allergy to tranexamic acid
  • History of any acquired disturbances of color vision
  • Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of <11 g/dL in females and <12 g/dL in males)
  • History of previous myocardial infarction
  • History of arterial or venous thromboembolic disease
  • History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.5, or a prolonged partial thromboplastin time
  • Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
  • Breastfeeding
  • Refusal of blood products
  • Preoperative use of anticoagulant therapy within five days before surgery
  • Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
  • Major comorbidities (e.g. severe ischemic heart disease )
  • Severe pulmonary disease
  • Preoperative blood donation
  • Participation in another clinical trial involving pharmaceutical drugs

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
Placebo Comparator: Group 1
Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Drug: Normal Saline Solution
Experimental: Group 2
Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Drug: Tranexamic Acid
Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Blood Loss
Time Frame: Pre Op, Post Op Day 2
Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.
Pre Op, Post Op Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid Thigh Circumference
Time Frame: Pre Op
Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.
Pre Op
Harris Hip Scores
Time Frame: Preoperative
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Preoperative
Harris Hip Scores
Time Frame: 2 week
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
2 week
Harris Hip Scores
Time Frame: 6 week
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
6 week

Collaborators and Investigators

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

Sponsor

Northwell Health

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

November 1, 2011

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (Estimate)

June 3, 2013

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-253

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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