Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study
- Conditions
- Intra-abdominal Abscess
- Interventions
- Drug: Saline
- Registration Number
- NCT01576679
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- 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.
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Pancreatic abscess (not bacterial in nature)
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Known coagulation impairment
-
Known central nervous system tumor or abscesses
-
Arteriovenous malformation
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Aneurysm or history of central nervous system bleeding
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Hypersensitivity to tPA
-
Recent administration of an investigational drug (within previous 30 days)
-
Pregnancy
-
Breast-feeding
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Fulminant hepatic failure
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Proven fistula (as it will alter the drainage time) or any abscess secondary to Crohn's Disease (because fistula existence cannot be excluded)
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Necrotizing enterocolitis
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Children requiring 4 or more drains
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tPA Cathflo (Alteplase) tissue Plasminogen Activator Placebo Saline Saline
- Primary Outcome Measures
Name Time Method Length of time the drain remains insitu 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.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada