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

NCT ID: NCT01576679

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-06-30

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.

Conditions

Intra-abdominal Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

tPA

tissue Plasminogen Activator

Group Type: EXPERIMENTAL

Cathflo (Alteplase)

Intervention Type: DRUG

Placebo

Saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Interventions

Cathflo (Alteplase)

Intervention Type: DRUG

Saline

Intervention Type: DRUG

Eligibility 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.

Exclusion Criteria

4. Patients and parents must have signed informed consent to participate in the study.

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Bairbre Connolly

Project Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bairbre Connolly, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000029136

Identifier Type: -

Identifier Source: org_study_id