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Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT01683955
Recruitment Status : Unknown
Verified February 2014 by Michael Laker, Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : September 12, 2012
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aims to assess postoperative blood loss and transfusion rates in total hip replacement after one-time administration of topical tranexamic acid.

Condition or disease Intervention/treatment Phase
Acute Blood Loss Anemia Osteoarthritis, Hip Drug: Transexamic Acid Drug: Placebo Phase 1

Detailed Description:
Autologous (donor) blood transfusion is an expensive and common occurrence after total hip replacement. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total hip replacements, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total hip arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty
Study Start Date : January 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Tranexamic Acid
Topical tranexamic acid (2g/100mL) applied during unilateral total hip arthroplasty.
Drug: Transexamic Acid
Topical tranexamic acid (2g/100mL 0.9% saline)
Other Name: cyclokapron
Placebo Comparator: Placebo
100mL 0.9% NS, applied topically
Drug: Placebo
100mL 0.9% sterile saline


Outcome Measures

Primary Outcome Measures :
  1. postoperative blood loss [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
    Preoperative and lowest postoperative hemoglobin


Secondary Outcome Measures :
  1. postoperative transfusion rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
    number of units transfused postoperatively


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients over age eighteen
  • Primary unilateral total hip arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)

Exclusion Criteria:

  • patient history of venous thromboembolic disease or coagulopathy
  • use of anticoagulant medications within 7 days of surgery
  • history of arterial embolic disease
  • history of Class III or IV heart failure
  • renal failure
  • intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683955


Contacts
Contact: Michael Laker, M.D. 248-514-8212 mlaker1@hfhs.org
Contact: Trevor North, M.B.B.S. 248-904-8743 tnorth1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48067
Contact: Michael Laker, M.D.    248-514-8212    mlaker1@hfhs.org   
Contact: Trevor North, M.B.B.S    248-904-8743    tnorth1@hfhs.org   
Principal Investigator: Michael W Laker, M.D.         
HFH Main campus Recruiting
Detroit, Michigan, United States, 48202
Contact: M Laker, MD    248-000-0000      
Contact: T North, MD    2489048743      
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Michael Laker, M.D. Henry Ford Health Systems
More Information

Responsible Party: Michael Laker, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01683955     History of Changes
Other Study ID Numbers: TEAHIPS
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by Michael Laker, Henry Ford Health System:
Tranexamic Acid
Blood transfusion
Total hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Hemorrhage
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants