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

The Hospital for Sick Children

Status and phase: Terminated; Phase 3

Conditions: Intra-abdominal Abscess

Treatments: Drug: Saline; Drug: Cathflo (Alteplase)

Study type: Interventional

Funder types: Other

Identifiers

NCT01576679

1000029136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

tPA

Experimental group

Description:

tissue Plasminogen Activator

Treatment:

Drug: Cathflo (Alteplase)

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Saline