Safety and Effectiveness of tPA in Intra-abdominal Abscesses
Phase 2
Terminated
- Conditions
- Abscess
- Interventions
- Other: Normal Saline
- Registration Number
- NCT00417768
- Lead Sponsor
- University Health Network, Toronto
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Intrabdominal abscess
Exclusion Criteria
- Hypersensitivity to tPA
- Recent stroke
- Uncontrolled htn
- Recent major hemorrhage
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Instillation of Normal Saline Normal Saline Insertion of abdominal drainage tube to drain intra-abdominal abscess. Normal Saline administered immediately post drain insertion. Normal Saline (10 cc) allowed to dwell for one hour, then allowed to drain into drainage bag. Tissue Plasminogen Activator Tissue Plasminogen Activator tPA administered by drainage tube into abscess, allowed to dwell for one hour and then drained into drainage bag. Dose of tPA administered to be determined by the volume of drainage immediately post drain insertion. This intervention is done on day 0, 1 and 2.
- Primary Outcome Measures
Name Time Method time to discharge time to eating radiological evidence of resolution
- Secondary Outcome Measures
Name Time Method cost comparison
Trial Locations
- Locations (1)
University Health Network
🇨🇦Toronto, Ontario, Canada