Phase 2
Completed N=20
Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
Abdominal Abscess · Pelvic Abscess
Source: ClinicalTrials.gov NCT00284739 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage — 3; 7 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage |
3; 7 | — |
| 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 |
82; 33 | — |
| SECONDARY Duration (in Days) of Percutaneous Drainage. |
6; 11 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00284739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.