Clinical trial NCT01683955: Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty
Official title: Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Blood Loss Anemia
Osteoarthritis, Hip
Keywords: Tranexamic Acid
Blood transfusion
Total hip arthroplasty
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: postoperative blood loss
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: postoperative transfusion rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: HFH Main campus
state: Michigan
Study officials:
affiliation: Henry Ford Health Systems
name: Michael Laker, M.D.
role: PRINCIPAL_INVESTIGATOR
References: