Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04555343 |
| Other study ID # |
FHREB 2020-085 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
October 30, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Fraser Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
We want to know:
- patient experience and acceptability of the intervention
- study procedures (recruitment, site appropriateness, staff engagement)
- safety data
- identify resource use
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.
