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Antifibrinolytic agent

Tranexamic Acid Methods for Blood Loss in Hip Replacement Surgery (VITALITY-X Trial)

Phase 4

Waitlist Available

Led By Paul Kuzyk, MD

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years at the time of surgery

Direct lateral (transgluteal, Hardinge) approach utilized, including augmentation with extended trochanteric osteotomy (ETO), trochanteric slide and modified trochanteric slide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months postoperatively

Awards & highlights

VITALITY-X Trial Summary

This trial will compare the effects of two methods of administering a drug to reduce blood loss during hip replacement surgery.

Who is the study for?

Adults over 18 needing revision hip arthroplasty can join this trial if they're okay with blood transfusions and have no issues with tranexamic acid. They must be having certain types of surgical approaches and willing to have surgery at MSH for conditions like osteolysis or joint infection.Check my eligibility

What is being tested?

The study is testing whether giving tranexamic acid through an IV or applying it directly on the tissue during hip replacement surgery affects blood loss, need for blood transfusion, hospital stay length, and complications after surgery.See study design

What are the potential side effects?

Tranexamic acid may cause side effects such as allergic reactions in those sensitive to it. It's also linked to increased risk of clotting events like heart attack or stroke in people who've had them before.

VITALITY-X Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My hip surgery was done using a specific approach that involves cutting through the gluteal muscles.

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I have had a hip revision surgery that involved changing or fixing parts of my hip joint.

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I had a hip replacement revision surgery at MSH.

VITALITY-X Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Delta Hemoglobin

Secondary outcome measures

Allogenic blood units transfused

Estimated intra-operative blood loss as assessed by the anaesthesiology team

Length of stay

+1 more

VITALITY-X Trial Design

2Treatment groups

Active Control

Group I: Topical TXAActive Control1 Intervention

The topical administration group will have a 100mL solution (3g TXA in 100cc of normal saline) instilled into the surgical field throughout the operative procedure; 50mL of the solution will be instilled after bony preparation of the acetabulum and/or femur and 50mL of the solution will be instilled prior to closure. The topical TXA solution will be allowed to bathe the wound for 5 minutes at each administration.

Group II: Intravenous TXAActive Control1 Intervention

The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor

196 Previous Clinical Trials

67,448 Total Patients Enrolled

Paul Kuzyk, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

1 Previous Clinical Trials

128 Total Patients Enrolled

Media Library

Hip Replacement Research Study Groups: Topical TXA, Intravenous TXA

Hip Replacement Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT02938962 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the patient cohort currently engaged in this medical experiment?

"This clinical trial has since ceased its recruitment efforts; it was listed on October 1st 2016 and last updated two weeks later. For those seeking to join a relevant medical study, there are currently 51 studies that focus on blood loss due to surgery as well as 61 trials regarding intravenous TXA actively recruiting participants."

Answered by AI

Could you provide a synopsis of previous research on Intravenous TXA?

"At the moment, 61 investigations are being conducted on Intravenous TXA with 26 of them in the critical Phase 3. Despite many studies for this intervention taking place in Kansas City, Kansas there exists a total of 185 locations running trials worldwide."

Answered by AI

To what extent is Intravenous TXA utilized to treat medical conditions?

"Intravenous TXA is regularly administered to treat hyperfibrinolysis and has also been used successfully in the alleviation of hemophilia, hemorrhaging, and post-extraction bleeding."

Answered by AI

Are recruitment efforts for this clinical trial currently ongoing?

"Unfortunately, this research has already concluded recruitment. It was initially advertised on October 1st 2016, and the advertisement was last edited on October 18th 2016. If you wish to participate in a similar study, there are 51 studies recruiting candidates with issues related to blood loss or surgery that involve intravenous TXA treatments."

Answered by AI