NCT02938962

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tranexamic Acid
• Blood Loss, Surgical
• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DRUG	Tranexamic Acid

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-11-01
• First posted: 2016-10-19
• Last updated: 2016-10-19

Locations

1 site across 1 country: Canada