Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Urinary Bladder Neoplasms

Hematuria

Urinary Retention

Urologic Diseases

Urogenital Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urination Disorders

Hemorrhage

Coagulants

All Drugs and Chemicals

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

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

Tranexamic acid

Ali Abdalvand, MD

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

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.

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

Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention

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

Patient triage time will be compared to time consent was obtained

all participants will have consent and intervention time documented

Both sites will document total number of patients recruited within study time

All participants will be followed throughout their hospital admission and all adverse events will be documented.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention	NCT04555343	Urologic Diseas... Prostate Cancer Bladder Cancer Urinary Retenti... Hematuria Nurse Physician... Nurse's Role Patient Satisfa...	Tranexamic acid	18 Years -	Fraser Health
Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention	NCT04555343	Urologic Diseas... Prostate Cancer Bladder Cancer Urinary Retenti... Hematuria Nurse Physician... Nurse's Role Patient Satisfa...	Tranexamic acid	18 Years -	Fraser Health

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