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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

Status
Terminated
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00417768
Enrollment
35
Registered
2007-01-04
Start date
2005-07-31
Completion date
2013-11-30
Last updated
2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscess

Keywords

tissue plasminogen activator, intraabdominal, abscess, percutaneous drainage

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.

Interventions

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.

OTHERNormal Saline

Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Intrabdominal abscess

Exclusion criteria

* Hypersensitivity to tPA * Recent stroke * Uncontrolled htn * Recent major hemorrhage * Pregnancy

Design outcomes

Primary

MeasureTime frame
time to eating
time to discharge
radiological evidence of resolution

Secondary

MeasureTime frame
cost comparison

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026