Skip to main content
Clinical Trials/NCT01683955
NCT01683955
Completed
Phase 1

Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty

Henry Ford Health System2 sites in 1 country139 target enrollmentJanuary 1, 2013

Overview

Phase
Phase 1
Intervention
Tranexamic acid
Conditions
Acute Blood Loss Anemia
Sponsor
Henry Ford Health System
Enrollment
139
Locations
2
Primary Endpoint
postoperative blood loss
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2013
End Date
November 3, 2013
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Arms & Interventions

Tranexamic Acid

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

Intervention: Tranexamic acid

Placebo

100mL 0.9% sterile saline, applied topically

Intervention: Placebo

Outcomes

Primary Outcomes

postoperative 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 Outcomes

  • postoperative transfusion rate(participants will be followed for the duration of hospital stay, an expected average of 3 days)

Study Sites (2)

Loading locations...

Similar Trials