Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Intra-abdominal Abscess

Intervention / Treatment
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* Drug: Cathflo (Alteplase)
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria:1. 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) Pregnancy 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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tPA<br>tissue Plasminogen Activator | Drug: Cathflo (Alteplase)<br> <br> |
| Placebo Comparator: Placebo<br>Saline | Drug: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time the drain remains insitu | 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. | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of any adverse event |  | up to 2 weeks | 
| The length of hospital stay |  | up to 2 months | 
| Rate of resolution of abscess |  | up to 2 weeks | 
| Return of clinical parameters to normal |  | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-abdominal, abscess, tPA, alteplase, cathflo