跳至主要内容
临床试验/NCT04555343
NCT04555343已完成1 期

Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention

Fraser Health2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Acceptability of study procedures to participants as assessed by successful consenting retention

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • complaint of hematuria or urinary retention
  • requiring CBI treatment
  • able to consent to the study.

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Tranexamic acid (Drug)

结局指标

主要结局

Acceptability of study procedures to participants as assessed by successful consenting retention

时间窗: 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

时间窗: 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

时间窗: 20 patients total or a maximum of six months

all participants will have consent and intervention time documented

次要结局

  • Trial site appropriateness as measured by total number of participants recruited within study time(20 patients total or a maximum of six months)
  • Incidence of treatment emergent adverse events as assessed by the CTCAE v3.0 severity scale(20 patients total or a maximum of six months)

研究者

发起方
Fraser Health
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验