Tranexamic Acid Study

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Arthroplasty, Replacement, Hip

Clinical Trial Details

NCT number	NCT00375440
Study type	Interventional
Source	Texas Tech University Health Sciences Center
Contact
Status	Withdrawn
Phase	N/A
Start date	February 2005
Completion date	January 2008

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05666479` - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Recruiting	`NCT03746925` - Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches	N/A
Completed	`NCT03008967` - A Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark	N/A
Completed	`NCT00980616` - Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)	Phase 2
Not yet recruiting	`NCT00958945` - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements	N/A
Completed	`NCT04542174` - PMCF 8 Year Results TRJ®
Not yet recruiting	`NCT04019925` - Assessing the Wear Rates of the ADM/MDM Hips Using 3D X-ray Analysis	N/A
Recruiting	`NCT06102811` - Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty	N/A
Recruiting	`NCT03570944` - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)
Recruiting	`NCT02938962` - Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X)	Phase 4
Completed	`NCT03076827` - Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol	N/A
Recruiting	`NCT02385383` - An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study	N/A
Completed	`NCT01444586` - Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)	N/A
Terminated	`NCT02525627` - A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads	N/A
Completed	`NCT00808483` - Walking Skill Training Program Effects in Patients With Total Hip Arthroplasty	N/A
Terminated	`NCT00958347` - Omnifit Hydroxylapatite (HA) Hip Outcomes Study	N/A
Completed	`NCT01422304` - Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)	Phase 3
Completed	`NCT04332055` - RCT Measuring the Effect of the ERVIN Software	N/A
Completed	`NCT01257568` - Rejuvenate Modular Outcomes Study	N/A
Recruiting	`NCT01031732` - Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.