CompletedPhase 1/2

Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention

Canada14 participantsStarted 2021-03-01

Plain-language summary

A study looking at the feasibility of doing a full-scale RCT that investigates the use of tranexamic acid intravesically prior to continuous bladder irrigation treatment in the emergency department for urinary retention due to clots. We want to know: * patient experience and acceptability of the intervention * study procedures (recruitment, site appropriateness, staff engagement) * safety data * identify resource use

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: * 18 years of age or older * complaint of hematuria or urinary retention * requiring CBI treatment * able to consent to the study. Exclusion Criteria: * Pregnancy or breastfeeding * Use of anticoagulants (warfarin, heparin, DOACs, etc.) * known coagulopathy (genetic bleeding disorders, acquired deficiencies) * urinary tract infection or pyelonephritis * known hypersensitivity to TXA * known renal failure * known or history of thrombosis/thromboembolism (retinal vein/artery occlusion, deep vein thrombosis, pulmonary embolism) * cognitive impairment rendering unable to provide informed consent and not having a substitute decision-maker present

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

Acceptability of study procedures to participants as assessed by successful consenting retention

Timeframe: 20 patients total or a maximum of six months

Participant recruitment time as measured by the time between identification of patient to consent completion

Timeframe: 20 patients total or a maximum of six months

Times to intervention- measured by time from consent to time intervention initiated

Timeframe: 20 patients total or a maximum of six months

Trial details

NCT IDNCT04555343

SponsorFraser Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

View on ClinicalTrials.gov More Urologic Diseases trials

Plain-language summary

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.

What they're measuring

Acceptability of study procedures to participants as assessed by successful consenting retention

Timeframe: 20 patients total or a maximum of six months

Participant recruitment time as measured by the time between identification of patient to consent completion

Timeframe: 20 patients total or a maximum of six months

Times to intervention- measured by time from consent to time intervention initiated

Timeframe: 20 patients total or a maximum of six months