Clinical trial NCT00375440: Tranexamic Acid Study
Official title: Randomized Placebo Controlled Study Using Tranexamic Acid in Revision Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Tranexamic Acid
Revision Total Hip Replacement
Reduction in Blood Loss
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2006-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if tranexamic acid significantly reduces blood loss and blood transfusion in revision total hip replacement. Tranexamic acid is a drug that helps to reduce blood loss during surgery. Revision total hip replacement surgery is treatment for patients who have previously had hipe replacement surgery which failed and must be repaired/replaced.

Detailed description: Tranexamic acid is an anti-fibrinolytic agent that inhibits fibrinolysis leading to a reduction of blood loss without concurrently increasing the risk of thromboembolic complications. Several studies have shown that tranexamic acid reduces blood loss and blood transfusions in primary total hip and knee arthroplasty. However, there have not been any studies that evaluate its efficacy in revision total hip arthroplasty. The significance of this study is that the need for blood transfusions and their complications may be minimized in revision hip arthroplasty if tranexamic acid is found to significantly decrease the amount of blood transfusions.

After the patient has been consented, he or she will be randomized into one of two groups (tranexamic acid and placebo) by the School of Pharmacy. The placebo will be crystalloid fluid of equal volume as tranexamic acid. The patient will then undergo revision total hip arthroplasty by Dr. Rosenstein and be administered tranexamic acid or placebo. Blood loss will be recorded intraoperatively and postoperatively through drains. Criteria for blood transfusion include hemoglobin less than 10g/dl or hematocrit less than 30%. Once the operation ends, the drug or placebo will be discontinued and the postoperative care is unchanged from current standards/protocols. Intraoperative blood loss, total blood loss, and number of blood transfusions will be recorded and analyzed. Length of acute hospital stay will also be recorded. A cost analysis will be performed comparing tranexamic acid to blood transfusions.

Eligibility criteria: Inclusion Criteria:

* Failed primary total hip arthroplasty (femoral stem, acetabular component, or both)
* 18-100 years of age

Exclusion Criteria:

* Prosthetic infection
* Primary total hip arthroplasty
* Prisoners
* Pregnancy
* Previous adverse reaction to tranexamic acid
* Bleeding/coagulation disorders
* Renal insufficiency (serum creatinine\>two standard deviations for age)
* History of deep venous thrombosis or pulmonary embolism
* Religious beliefs/practices prohibiting blood transfusions
* Wards of the state
* Cognitively impaired patients
* Terminally ill patients
* Students and/or employees
* Color blindness

Primary outcomes:
measure: Introperative blood loss
measure: Total blood loss
measure: Number of blood transfusions required
Secondary outcomes:
measure: Length of acute hospital stay
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center Department of Orthopaedic Surgery
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center Department of Orthopaedic Surgery
name: Alexander D Rosenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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