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Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

Primary Purpose

Acute Blood Loss Anemia, Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Blood Loss Anemia focused on measuring Tranexamic Acid, Blood transfusion, Total knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

Placebo

Arm Description

Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.

100mL 0.9% NS, applied topically

Outcomes

Primary Outcome Measures

Blood Loss
Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146).

Secondary Outcome Measures

Postoperative Transfusion Rate
Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.

Full Information

First Posted
June 3, 2011
Last Updated
March 30, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01370460
Brief Title
Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty
Official Title
Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry Ford Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Blood Loss Anemia, Osteoarthritis, Knee
Keywords
Tranexamic Acid, Blood transfusion, Total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100mL 0.9% NS, applied topically
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Cyklokapron
Intervention Description
Topical tranexamic acid (2g/100mL 0.9% saline)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100mL 0.9% sterile saline
Primary Outcome Measure Information:
Title
Blood Loss
Description
Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146).
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary Outcome Measure Information:
Title
Postoperative Transfusion Rate
Description
Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Laker, M.D.
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21936146
Citation
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
Results Reference
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PubMed Identifier
12697586
Citation
Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.
Results Reference
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Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

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