NCT00417768

Safety and Effectiveness of tPA in Intra-abdominal Abscesses

Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine if instillation of tissue plasminogen activator into a percutaneously drained intra-abdominal abscess cavity results in faster resolution of the abscess compared to normal standard of care.

Detailed description

On day 0 Subjects will have Tissue Plasminogen Activator injected into a drainage tube and allowed to dwell in the intra-abdominal abscess for one hour before allowing it to drain by gravity. This will be repeated on day 1 and 2.

Conditions

• Abscess

Interventions

Type	Name	Description
DRUG	Tissue Plasminogen Activator	The dosage of tPA is determined by the volume of drainage obtained when abscess is first drained. The same dose will be repeated on day 1 and 2.
OTHER	Normal Saline	Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.

Timeline

• Start date: 2005-07-01
• Primary completion: 2012-07-01
• Completion: 2013-11-01
• First posted: 2007-01-04
• Last updated: 2014-01-14

Locations

1 site across 1 country: Canada