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

• Status: Terminated
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Plasminogen; Tissue Plasminogen Activator

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