Abdominal Abscess Clinical Trial
Official title:
Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Foundation Hospital | Honolulu | Hawaii |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage | 30 days | No | |
Secondary | Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement | This is the percentage of participants in whom their loculated abscess completely resolve with percutaneous drainage at the time of the first followup CT performed at 3 days after start of the intervention and therefore do NOT require additional surgical intervention. | 3 days | No |
Secondary | Duration (in Days) of Percutaneous Drainage. | The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days. | Up to 30 days | No |
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