Status:
COMPLETED
Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Abdominal Abscess
Pelvic Abscess
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The use of fibrinolytics for the percutaneous drainage of loculated pleural effusions has been shown to reduce the catheter dwell time and to improve drainage of the effusions. Abscesses in the abdome...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00284739
Start Date
February 1 2006
End Date
October 1 2007
Last Update
February 26 2015
Active Locations (1)
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1
Kaiser Foundation Hospital
Honolulu, Hawaii, United States, 96819