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Trial record 55 of 419 for:    TRANEXAMIC ACID

Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01370460
Recruitment Status : Completed
First Posted : June 10, 2011
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):
Michael Laker, Henry Ford Health System

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

Condition or disease Intervention/treatment Phase
Acute Blood Loss Anemia Osteoarthritis, Knee Drug: Tranexamic Acid Drug: Placebo Phase 2

Detailed Description:
Autologous (donor) blood transfusion is an expensive and common occurrence after total knee replacement. Published data puts this rate between 9 and 40% after primary unilateral total knee arthroplasty. 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 knee replacement, 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 knee arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. Furthermore, the one aforementioned randomized clinical trial used a variety of postoperative deep vein thrombosis prophylaxis after surgery and introduced a potential confounding variable. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 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 Knee Arthroplasty
Study Start Date : June 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tranexamic Acid
Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
Drug: Tranexamic Acid
Topical tranexamic acid (2g/100mL 0.9% saline)
Other Name: Cyklokapron

Placebo Comparator: Placebo
100mL 0.9% NS, applied topically
Drug: Placebo
100mL 0.9% sterile saline

Primary Outcome Measures :
  1. 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 patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • All adult patients over age eighteen
  • Primary unilateral total knee 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).

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 identifier (NCT number): NCT01370460

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United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
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Principal Investigator: Michael Laker, M.D. Henry Ford Health System

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Responsible Party: Michael Laker, MD, Henry Ford Health System Identifier: NCT01370460     History of Changes
Other Study ID Numbers: IRB 6669
First Posted: June 10, 2011    Key Record Dates
Results First Posted: July 9, 2013
Last Update Posted: July 9, 2013
Last Verified: July 2013
Keywords provided by Michael Laker, Henry Ford Health System:
Tranexamic Acid
Blood transfusion
Total knee arthroplasty
Additional relevant MeSH terms:
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Tranexamic Acid
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action