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Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention

Primary Purpose

Urologic Diseases, Prostate Cancer, Bladder Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Fraser Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Columbian Hospital
  • Eagle Ridge Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention- TXA

Arm 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

Outcomes

Primary Outcome Measures

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
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
Times to intervention- measured by time from consent to time intervention initiated
all participants will have consent and intervention time documented

Secondary Outcome Measures

Trial site appropriateness as measured by total number of participants recruited within study time
Both sites will document total number of patients recruited within study time
Incidence of treatment emergent adverse events as assessed by the CTCAE v3.0 severity scale
All participants will be followed throughout their hospital admission and all adverse events will be documented.

Full Information

First Posted
August 14, 2020
Last Updated
November 4, 2021
Sponsor
Fraser Health
Collaborators
BC Support Unit, Michael Smith Foundation for Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT04555343
Brief Title
Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention
Official Title
Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraser Health
Collaborators
BC Support Unit, Michael Smith Foundation for Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Urinary retention due to high clot burden is a common and resource-intensive condition. Patients who have recently had prostate surgery or who have bladder cancer can often present with urinary retention due to clots. Currently, the standard treatment for hematuria and clot retention that has led to urinary retention is continuous bladder irrigation (CBI) treatment. CBI treatment is a nursing intensive procedure that is associated with lengthy hospital stays for the patient. CBI treatment is a catheter inserted into the urethral opening that allows a continuous flow of irrigation fluid into and out of the bladder. Initial manual irrigation of clots is also a part of the standard of care. Catheter insertion is a painful procedure, and there is distress during treatment as patients are confined to bed and experience discomfort related to the catheter blockage. CBI treatment may be discontinued as the urine clears of blood only to have it restarted as new clots form. CBI treatment requires a high level of nursing resources as the irrigation fluid must be regularly changed and removed. It also tends to require multiple episodes of manual irrigation by the nurse when it becomes blocked. The procedure is not only distressing and invasive for the patient, but also takes away resources from other patients. The procedure is labor intensive for nursing staff as it requires constant monitoring and frequent episodes of lengthy manual clot irrigation resulting in nursing resource strain and neglect of other patients. There has been recent interest in adding antifibrinolytics, such as tranexamic acid (TXA), to the standard treatment protocol to stop hematuria and clot retention and thereby decrease patient and staff burden and improve outcomes. TXA is a synthetic lysine analog that prevents the breakdown of clots and facilitates clot stabilization to promote tissue healing. It intervenes at the end of the coagulation pathway to promote clot stabilization. The bladder and prostate are prone to clot breakdown and therefore hematuria, as their tissue naturally promotes clot breakdown. For this reason, TXA has been used extensively in urological surgeries to prevent bleeding complications and has demonstrated effectiveness with an excellent safety profile. Historically, TXA was given either orally, intramuscularly, or intravenously. However, there is increasing interest in using TXA topically due to a decreased systemic absorption of TXA compared to oral or intravenous use. Our team is interested in exploring the effect TXA has when administered intravesically - i.e., instilled directly into the bladder. Specifically, we are proposing the use of TXA directly into the bladder to obtain preliminary data about the effects on the clinical course of patients requiring CBI treatment for hematuria and clot retention. Intervention: A 22-24F three-way Foley catheter will be inserted as per standard nursing protocols, and the treating nurse will manually irrigate the bladder to remove as many clots as possible upon catheter insertion before TXA instillation. One gram of TXA will be mixed with 100 ml of normal saline, then directly instilled into the bladder via the catheter. The catheter will be clamped with the medication in-situ for 15 minutes to allow the medication to have sufficient time in contact with the bladder tissue. After 15 minutes, the catheter will be unclamped, and CBI treatment will be carried out as per standard treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases, Prostate Cancer, Bladder Cancer, Urinary Retention, Hematuria, Nurse Physician Relations, Nurse's Role, Patient Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
convenience sampling of patients presenting to the emergency, all receiving intervention, no blinding
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention- TXA
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
TXA
Intervention Description
1gm instilled instravesically
Primary Outcome Measure Information:
Title
Acceptability of study procedures to participants as assessed by successful consenting retention
Description
measured by the number of eligible patients and number that consent to the study intervention
Time Frame
20 patients total or a maximum of six months
Title
Participant recruitment time as measured by the time between identification of patient to consent completion
Description
Patient triage time will be compared to time consent was obtained
Time Frame
20 patients total or a maximum of six months
Title
Times to intervention- measured by time from consent to time intervention initiated
Description
all participants will have consent and intervention time documented
Time Frame
20 patients total or a maximum of six months
Secondary Outcome Measure Information:
Title
Trial site appropriateness as measured by total number of participants recruited within study time
Description
Both sites will document total number of patients recruited within study time
Time Frame
20 patients total or a maximum of six months
Title
Incidence of treatment emergent adverse events as assessed by the CTCAE v3.0 severity scale
Description
All participants will be followed throughout their hospital admission and all adverse events will be documented.
Time Frame
20 patients total or a maximum of six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Abdalvand, MD
Organizational Affiliation
Fraser Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Eagle Ridge Hospital
City
Port Moody
State/Province
British Columbia
ZIP/Postal Code
V3H 3W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention

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