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临床试验/ACTRN12622001280796
ACTRN12622001280796尚未招募1 期

A double-blind, placebo controlled randomised study to assess the tolerability, safety, and preliminary efficacy of taurolidine-citrate lock solution (TauroLock™) in patients with recurrent pleural effusions requiring management with Indwelling Pleural Catheters for recurrent effusion drainage.

St John of God Midland Hospital0 个研究点目标入组 18 人开始时间: 2022年9月29日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
18

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1. Patients with an Indwelling Pleural Catheter (IPC) for recurrent pleural effusion who consent to the trial.
  • 2. Must be within community nursing service catchment (e.g. Silver Chain) and be able to attend follow up appointments at SJOG Midland as required.

排除标准

  • 1. Patients unable to provide informed consent
  • 2. Life expectancy <3 months
  • 3. Known adverse reaction to taurolidine or citrate
  • 4. Patient requiring other intrapleural medication
  • 5. Active bleeding of sufficient severity to warrant hospital admission or withholding of regular anticoagulation therapy
  • 6. Severe renal impairment (eGFR <30)
  • 7. Concurrent pregnancy, lactation
  • 8. Patients with previous documented pleural infection within 6 months
  • 9. Uncontrolled pain at baseline

研究者

发起方
St John of God Midland Hospital

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