Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2013-11-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Blood Loss Anemia Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tranexamic Acid

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

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

Topical tranexamic acid (2g/100mL 0.9% saline)

Placebo

100mL 0.9% sterile saline, applied topically

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100mL 0.9% sterile saline

Interventions

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Tranexamic acid

Topical tranexamic acid (2g/100mL 0.9% saline)

Intervention Type DRUG

Placebo

100mL 0.9% sterile saline

Intervention Type DRUG

Other Intervention Names

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cyclokapron

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No