A Double Blind, Randomized Controlled Trial Examining the Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-abdominal Collections in Children - a Prospective Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Length of time the drain remains insitu
研究概览
简要总结
The objective of this study is to establish the efficacy of tPA when used in pediatric intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the ultrasound appearance or consistency of the drained fluid.
详细描述
The use of tPA in pediatric abdominal abscesses is poorly defined. The indications are somewhat subjective and the dosage guidelines vary between institutions. Some studies have suggested that it be administered at, or soon after, the time of drainage if the ultrasound appearance of the collection is complex and/or septated, or if the initial aspirated contents are thick and viscous. Both criteria are difficult to accurately define and implement. In many instances, when there is minimal ongoing drainage despite follow-up ultrasound appearances suggesting a significant residual collection, tPA is administered several days following the initial procedure.
The purpose of this study is to establish the efficacy of tPA in the initial treatment of all pediatric intra-abdominal abcesses and a standardized manner in which it can be used. This may eventually lead to a change in practice in the management of this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains).
- •Drain(s) must be inserted within the 23hrs prior to enrollment in the study.
- •The underlying diagnosis of the condition will not affect the enrollment of the patient unless it is detailed within the exclusion criteria (section 4.1.2).
- •Patients and parents must have signed informed consent to participate in the study.
排除标准
- •Pancreatic abscess (not bacterial in nature)
- •Known coagulation impairment
- •Known central nervous system tumor or abscesses
- •Arteriovenous malformation
- •Aneurysm or history of central nervous system bleeding
- •Hypersensitivity to tPA
- •Recent administration of an investigational drug (within previous 30 days)
- •Breast-feeding
- •Fulminant hepatic failure
- •Proven fistula (as it will alter the drainage time) or any abscess secondary to Crohn's Disease (because fistula existence cannot be excluded)
- •Necrotizing enterocolitis
- •Children requiring 4 or more drains
研究组 & 干预措施
tPA
tissue Plasminogen Activator
干预措施: Cathflo (Alteplase) (Drug)
Placebo
Saline
干预措施: Saline (Drug)
结局指标
主要结局
Length of time the drain remains insitu
时间窗: up to 2 weeks
The primary outcome is the length of time (in hours) the drain remains insitu. For the primary outcome the individual abscess will be the unit of measurement; if there are multiple abscesses (up to a maximum of three) in the one patient each abscess will receive the same treatment. In the case of more than one drain being inserted in a single patient, the length of time that each drain remains in situ will be recorded individually.
次要结局
- Documentation of any adverse event(up to 2 weeks)
- Rate of resolution of abscess(up to 2 weeks)
- Return of clinical parameters to normal(up to 2 weeks)
- The length of hospital stay(up to 2 months)
研究者
Bairbre Connolly
Project Investigator
The Hospital for Sick Children