Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: Genentech, Inc.
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.

• Age > 18 years

• Adult, non-gravid patients with loculated abdominopelvic abscesses immediately after percutaneous drainage will be eligible to participate. A loculated abscess is defined as an abscess whose contents cannot be completely drained at the time of initial catheter placement as documented on CT.

Exclusion Criteria:

• Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts

• History of stroke within 6 months

• Uncorrectable bleeding diathesis (INR > 1.3 despite therapy)

• Recent intracranial or intraspinal surgery or trauma

• Pregnancy (positive pregnancy test)

• Pancreatic abscesses

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another simultaneous medical investigation or trial

• Participation in another clinical investigation within previous 30 days of catheter placement

• Prior enrollment in the study

• Known allergy to Alteplase or any of its components