Urologic DiseasesPhase 1/2NCT04555343
Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention
A Phase 1/2 study testing Tranexamic acid in people with Urologic Diseases and Prostate Cancer, run by Fraser Health at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Prostate Cancer, Bladder Cancer
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Mar 2021to 30 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- complaint of hematuria or urinary retention
- requiring CBI treatment
- able to consent to the study.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Eagle Ridge Hospital
Port Moody, British Columbia, V3H 3W9
About this study
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
Read the 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.
- Conditions
- Urologic Diseases, Prostate Cancer, Bladder Cancer, Urinary Retention, Hematuria, Nurse Physician Relations
- Being tested
- Tranexamic acid
- Medical subject headings
- Urologic Diseases, Prostatic Neoplasms, Urinary Bladder Neoplasms, Urinary Retention, Hematuria, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called TXA
1gm instilled instravesically
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Both sites will document total number of patients recruited within study time
Measured: 20 patients total or a maximum of six months
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.
Measured: 20 patients total or a maximum of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Mar 2021
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- convenience sampling of patients presenting to the emergency, all receiving intervention, no blinding
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- BC Support Unit, Michael Smith Foundation for Health Research
- Responsible party
- Sponsor
- Investigators
- Ali Abdalvand, MD, Principal investigator, Fraser Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555343
- Sponsor's protocol ID
- FHREB 2020-085
- Status last verified
- Nov 2021
- First submitted
- 14 Aug 2020
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention
- ClinicalTrials.gov ID
- NCT04555343
- Acronym / sponsor ID
- FHREB 2020-085
- Conditions
- Urologic Diseases, Prostate Cancer, Bladder Cancer, Urinary Retention, Hematuria, Nurse Physician Relations
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- BC Support Unit, Michael Smith Foundation for Health Research
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- convenience sampling of patients presenting to the emergency, all receiving intervention, no blinding
| Arm | Type | Receives |
|---|---|---|
| Intervention- TXA | Experimental | Drug: Tranexamic acidDrug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- complaint of hematuria or urinary retention
- requiring CBI treatment
- able to consent to the study.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: TXA1gm instilled instravesically | Drug | Intervention- TXA |
Primary outcome
Acceptability of study procedures to participants as assessed by successful consenting retention
Time frame: 20 patients total or a maximum of six months
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
Time frame: 20 patients total or a maximum of six months
Patient triage time will be compared to time consent was obtained
Times to intervention- measured by time from consent to time intervention initiated
Time frame: 20 patients total or a maximum of six months
all participants will have consent and intervention time documented
2 secondary outcomes
Trial site appropriateness as measured by total number of participants recruited within study time
Time frame: 20 patients total or a maximum of six months
Incidence of treatment emergent adverse events as assessed by the CTCAE v3.0 severity scale
Time frame: 20 patients total or a maximum of six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Abdalvand, MD principal investigator
Fraser Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic acid in people with Urologic Diseases and Prostate Cancer, run by Fraser Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of study procedures to participants as assessed by successful consenting retention (time frame: 20 patients total or a maximum of six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.