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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

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT04555343
Study type Interventional
Source Fraser Health
Status Completed
Phase Phase 1/Phase 2
Start date March 1, 2021
Completion date October 30, 2021

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