Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip; Acute Blood Loss Anemia
• Intervention / Treatment: Drug: Placebo; Drug: Tranexamic acid

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 Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael Laker, M.D.; Phone Number: 248-514-8212; Email: mlaker1@hfhs.org
• Study Contact Backup: Name: Trevor North, M.B.B.S.; Phone Number: 248-904-8743; Email: tnorth1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48067
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48202
      • HFH Main campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid; Topical tranexamic acid (2g/100mL) applied during unilateral total hip arthroplasty.	Drug: Tranexamic acid; Topical tranexamic acid (2g/100mL 0.9% saline); Other Names: cyclokapron
Placebo Comparator: Placebo; 100mL 0.9% sterile saline, applied topically	Drug: Placebo; 100mL 0.9% sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative blood loss	Preoperative and lowest postoperative hemoglobin	participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative transfusion rate	number of units transfused postoperatively	participants will be followed for the duration of hospital stay, an expected average of 3 days

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Michael Laker, M.D., Henry Ford Health Systems

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): November 3, 2013
• Study Completion (Actual): November 3, 2013

Study Registration Dates

• First Submitted: September 8, 2012
• First Submitted That Met QC Criteria: September 8, 2012
• First Posted (Estimate): September 12, 2012

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Total hip arthroplasty; Tranexamic Acid; Blood transfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Hemorrhage; Osteoarthritis, Hip; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TEAHIPS