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

Phase 3TerminatedNCT01576679

The Hospital for Sick Children28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Intra-abdominal Abscess

Interventions

Cathflo (Alteplase)DRUG

SalineDRUG

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains). 2. Drain(s) must be inserted within the 23hrs prior to enrollment in the study. 3. 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). 4. Patients and parents must have signed informed consent to participate in the study. Exclusion Criteria:1. 1. Pancreatic abscess (not bacterial in nature) 2. Known coagulation impairment 3. Known central nervous system tumor or abscesses 4. Arteriovenous malformation 5. Aneurysm or history of central nervous system bleeding 6. Hypersensitivity to tPA 7. Recent administration of an investigational drug (within previous 30 days) 8. Pregnancy 9. Breast-feeding 10. Fulminant hepatic failure 11. Proven fistula (as it will alter the drainage time) or any abscess secondary to Crohn's Disease (because fistula existence cannot be excluded) 12. Necrotizing enterocolitis 13. Children requiring 4 or more drains

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: up to 2 weeks

Secondary Outcomes

Documentation of any adverse event

Time frame: up to 2 weeks

The length of hospital stay

Time frame: up to 2 months

Rate of resolution of abscess

Time frame: up to 2 weeks

Return of clinical parameters to normal

Time frame: up to 2 weeks

Data from ClinicalTrials.gov

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