Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Laker, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01370460
First received: June 3, 2011
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Blood Loss [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: Yes ]
    Preoperative and lowest postoperative hemoglobin


Secondary Outcome Measures:
  • Postoperative Transfusion Rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: Yes ]
    Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.


Enrollment: 101
Study Start Date: June 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370460

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

Publications:
Responsible Party: Michael Laker, MD, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01370460     History of Changes
Other Study ID Numbers: IRB 6669
Study First Received: June 3, 2011
Results First Received: March 27, 2013
Last Updated: July 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Tranexamic Acid
Blood transfusion
Total knee arthroplasty

Additional relevant MeSH terms:
Anemia
Hemorrhage
Osteoarthritis
Anemia, Hypochromic
Osteoarthritis, Knee
Hematologic Diseases
Pathologic Processes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
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 August 21, 2014