Clinical Trials Logo
  1. Home
  2. Arthroplasty, Replacement, Hip
  3. NCT02938962

Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X) — VITALITY-X  

Arthroplasty, Replacement, Hip Clinical Trial

Official title:
Revision Total Hip Arthroplasty: Comparison of the Effects of Intravenous and Topically Administered Tranexamic Acid in a Prospective Randomized Trial (VITALITY-X)

Clinical Trial Summary

The objective of this study is to evaluate and compare the effects of intravenous and topical administration of tranexamic acid during revision hip arthroplasty on blood loss, allogenic blood transfusion rates, length of hospital stay and perioperative complications.

Clinical Trial Description

This study will use a prospective randomized single-blinded study design. The study will include one hundred and sixty patients undergoing revision total hip arthroplasty at a single institution (Mount Sinai Hospital (MSH), Toronto, ON, Canada). Tranexamic acid has been routinely administered as a single intravenous preoperative dose (unless contraindicated) in all revision hip arthroplasty cases at MSH since May 2012. In this study, participants will be randomized into 2 treatment groups: intravenous (IV) administration of tranexamic acid (TXA) and topical administration of TXA. The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision. The topical administration group will have a 100mL solution (3g TXA in 100cc of normal saline) instilled into the surgical field during surgery. The primary outcome measured will be the delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to POD 0, 1, 2, 3, 5). Secondary outcomes to be analyzed include intraoperative estimated blood loss, allogenic blood transfusion rates, length of hospital stay and postoperative complications. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02938962
Study type Interventional
Source Mount Sinai Hospital, Canada
Contact Paul Kuzyk, MD
Phone 416-586-4653
Email pkuzyk@mtsinai.on.ca
Status Recruiting
Phase Phase 4
Start date October 2016
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
Not yet recruiting NCT00958945 - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements N/A
Completed NCT00980616 - Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA) Phase 2
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)
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
Completed NCT00797264 - Ketamine Associated With Morphine PCA After Total Hip Arthroplasty N/A