Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- time to discharge
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Intrabdominal abscess
Exclusion Criteria
- •Hypersensitivity to tPA
- •Recent stroke
- •Uncontrolled htn
- •Recent major hemorrhage
- •Pregnancy
Arms & Interventions
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.
Intervention: Tissue Plasminogen Activator (Drug)
Instillation of 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.
Intervention: Normal Saline (Other)
Outcomes
Primary Outcomes
time to discharge
time to eating
radiological evidence of resolution
Secondary Outcomes
- cost comparison