None listed
Conditions
Brief summary
This is a triple-blind, randomised, placebo-controlled trial investigating whether a single intravesical dose of tranexamic acid (TXA) reduces the duration of continuous bladder irrigation (CBI) in adults presenting to the Emergency Department with macroscopic haematuria. Macroscopic haematuria (blood visible in urine) can cause clots in the bladder, leading to urinary obstruction that requires a bladder catheter and CBI. TXA is a medicine that helps stop bleeding by preventing clot breakdown. Adults aged 18 or over with macroscopic haematuria requiring CBI will be randomly assigned to receive either 1000mg TXA in 100ml saline or a placebo (100ml saline alone), instilled into the bladder via urinary catheter and clamped for 15 minutes before CBI starts. Neither participants nor treating staff will know which treatment is given. The main outcome is how long CBI is needed. Secondary outcomes include hospital admission rates, emergency department re-presentations, catheter duration, and safety outcomes including venous thromboembolism. 80 participants will be recruited across four Emergency Departments in the Illawarra Shoalhaven Local Health District, NSW, over 12 months.
Interventions
1000mg of tranexamic acid (Tranexamic-AFT, AFT Pharmaceuticals) dissolved in 100ml of 0.9% normal saline is instilled into the bladder via the main lumen of an indwelling urinary catheter (3-way IDC, minimum size 20Fr). The catheter is clamped for 15 minutes. After unclamping, the solution is drained and continuous bladder irrigation (CBI) is commenced immediately without delay.
The study drug is prepared by a designated unblinded clinician (Study Clinician 2) in a container labelled only with
1000mg of tranexamic acid (Tranexamic-AFT, AFT Pharmaceuticals) dissolved in 100ml of 0.9% normal saline is instilled into the bladder via the main lumen of an indwelling urinary catheter (3-way IDC, minimum size 20Fr). The catheter is clamped for 15 minutes. After unclamping, the solution is drained and continuous bladder irrigation (CBI) is commenced immediately without delay. The study drug is prepared by a designated unblinded clinician (Study Clinician 2) in a container labelled only with the participant's study ID, identical in appearance to the placebo. Prior to study drug administration, manual bladder washout is completed until all intravesical clots are removed based on bedside clinical assessment. Mode of delivery: Intravesical instillation via indwelling urinary catheter in the Emergency Department. Dose: 1000mg TXA in 100ml 0.9% normal saline. Duration: Single administration with 15-minute dwell time. Location: Emergency Department (Wollongong Hospital, Shoalhaven District Memorial Hospital, Shellharbour Hospital, Milton Ulladulla Hospital). Continuous bladder irrigation will be standardized for the purposes of the trial, and patients included in the study would have normally been treated with CBI if the study was not taking place. CBI is the process of irrigating the bladder with normal saline through a 3-way indwelling urinary catheter. The rate of CBI started at 100 drops/min and then titrated to the colour of the urine output. CBI is ceased when the urine becomes clear. There is not a specific maximum time duration for CBI.
Sponsors
Illawarra Shoalhaven Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or over. 2. Clinically significant macroscopic haematuria requiring indwelling urinary catheter (IDC) placement and initiation of continuous bladder irrigation (CBI), based on at least one of: - Clinical judgement and urine colour assessment; and/or - Urinary retention secondary to suspected intravesical clot. 3. Willingness to give written or oral informed consent. 4. Willingness to participate in and comply with the study.
Exclusion criteria
1. Haematuria in the context of suspected or proven upper or lower urinary tract trauma (excluding IDC-related superficial prostatic trauma with externally dislodged IDC requiring further management). 2. Suspected bladder perforation for any reason. 3. Documented tranexamic acid allergy. 4. Not suitable for IDC placement or unable to undergo manual bladder washout prior to study drug administration. 5. Patients with CBI already initiated. 6. Known or suspected pregnancy or breastfeeding. 7. Known or suspected organised intravesical clot unresponsive to manual irrigation. 8. Lacks capacity to provide informed consent at the time consent is sought. 9. Any other condition that, in the opinion of the treating clinician or principal investigator, would make participation unsafe or compromise study integrity. 10. Previously enrolled participants (no re-enrolment).
Outcome results
None listed