NCT01576679

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Cathflo (Alteplase)
DRUG	Saline

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-05-01
• Completion: 2017-06-01
• First posted: 2012-04-12
• Last updated: 2019-06-27

Locations

1 site across 1 country: Canada