Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention

NCT04555343 | Completed Phase 1

• 1 other identifier: FHREB 2020-085
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Urologic Diseases; Prostate Cancer; Bladder Cancer; Urinary Retention; Hematuria; Nurse Physician Relations; Nurse's Role; Patient Satisfaction

Outcome Measures

Primary Outcomes (3)

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

  measured by the number of eligible patients and number that consent to the study intervention

  20 patients total or a maximum of six months

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

  Patient triage time will be compared to time consent was obtained

  20 patients total or a maximum of six months

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

  all participants will have consent and intervention time documented

  20 patients total or a maximum of six months

Secondary Outcomes (2)

• Trial site appropriateness as measured by total number of participants recruited within study time

  20 patients total or a maximum of six months

• Incidence of treatment emergent adverse events as assessed by the CTCAE v3.0 severity scale

  20 patients total or a maximum of six months

Study Arms (1)

Intervention- TXA

EXPERIMENTAL

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

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

1gm instilled instravesically

Also known as: TXA

Intervention- TXA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• complaint of hematuria or urinary retention
• requiring CBI treatment
• able to consent to the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraser Health: lead
• BC Support Unit: collaborator
• Michael Smith Foundation for Health Research: collaborator

Study Sites (2)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Eagle Ridge Hospital

Port Moody, British Columbia, V3H 3W9, Canada

Location

MeSH Terms

Conditions

Urologic Diseases; Prostatic Neoplasms; Urinary Bladder Neoplasms; Urinary Retention; Hematuria; Patient Satisfaction

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urination Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ali Abdalvand, MD

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: convenience sampling of patients presenting to the emergency, all receiving intervention, no blinding

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: September 18, 2020
• Study Start: March 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)