UnknownPhase 4

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

Canada160 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years at the time of surgery. * Consent for transfusion of blood or blood-related products. * No contraindication to use of tranexamic acid. * Revision hip arthroplasty performed at MSH. * Indication for surgery including osteolysis, component failure, prosthetic joint infection, aseptic/septic loosening, periprosthetic fracture, recurrent instability/dislocation, polyethylene wear and abductor insufficiency. * Revision hip arthroplasty procedure performed including acetabular component revision, femoral component revision, impaction bone grafting, proximal femoral allograft, proximal femoral replacement, removal of hardware (excluding head/liner exchanges). * Direct lateral (transgluteal, Hardinge) approach utilized, including augmentation with extended trochanteric osteotomy (ETO), trochanteric slide and modified trochanteric slide. Exclusion Criteria: * Age \< 18 years at the time of surgery. * Posterior (Moore, Southern) or Anterior (Smith-Peterson) operative approach utilized. * Implantation of surgical drain. * Patients undergoing any isolated combination of femoral head exchange, acetabular liner exchange and abductor repair. * Patients with an absolute contraindication to tranexamic acid use including: * Allergy to TXA or previous adverse reaction to TXA/its constituents. * Thrombolytic events \<1 year prior to surgery (myocardial infarction, cerebrovascular accident, pulmonary embolus). * Active thrombolytic event and/or on lifelong …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Delta Hemoglobin

Timeframe: Post-operative day #0 to post-operative day #5

Trial details

NCT IDNCT02938962

SponsorMount Sinai Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11

Contact for this trial

Paul Kuzyk, MD

416-586-4653 pkuzyk@mtsinai.on.ca

View on ClinicalTrials.gov More Tranexamic Acid trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.