Clinical trial · Interventional
Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention
NCT04555343CI-TRIAL-00054913completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Hematuria | — | UNRESOLVED | — |
| Nurse Physician Relations | — | UNRESOLVED | — |
| Nurse's Role | — | UNRESOLVED | — |
| Patient Satisfaction | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Retention | — | UNRESOLVED | — |
| Urologic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tranexamic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention- TXA
- description
- Drug: one-time intravesical administration of 1gm of TXA instilled via urinary catheter, instilled for 15min before continuous bladder irrigation treatment beings. 1gm of TXA will be mixed with 100cc NS
- interventionNames
- Drug: Tranexamic acid
Primary outcomes (3)
- measure
- Acceptability of study procedures to participants as assessed by successful consenting retention
- timeFrame
- 20 patients total or a maximum of six months
- description
- measured by the number of eligible patients and number that consent to the study intervention
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.