Title
Safety and Effectiveness of tPA in Intra-abdominal Abscesses
Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial
Phase
Phase 2/Phase 3Lead Sponsor
University of TorontoStudy Type
InterventionalStatus
TerminatedIndication/Condition
AbscessIntervention/Treatment
alteplase sodium chloride ...Study Participants
35To 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.
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.
The dosage of tPA is determined by the volume of drainage obtained when abscess is first drained. The same dose will be repeated on day 1 and 2.
Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.
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.
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.
Inclusion Criteria: Intrabdominal abscess Exclusion Criteria: Hypersensitivity to tPA Recent stroke Uncontrolled htn Recent major hemorrhage Pregnancy
