Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty

Phase 1

Completed

• Conditions: Acute Blood Loss Anemia; Osteoarthritis, Hip
• Interventions: Drug: Placebo; Drug: Tranexamic acid

• Registration Number: NCT01683955
• Lead Sponsor: Henry Ford Health System

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.

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 Timeline

• Study First Submitted: 2012-09-08
• Study First Submitted QC: 2012-09-08
• Study First Posted: 2012-09-12
• Study Start: 2013-01-01
• Primary Completion: 2013-11-03
• Study Completion: 2013-11-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	100mL 0.9% sterile saline, applied topically
Tranexamic Acid	Tranexamic acid	Topical tranexamic acid (2g/100mL) applied during unilateral total hip arthroplasty.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

HFH Main campus; 🇺🇸 Detroit, Michigan, United States