Safety and Effectiveness of tPA in Intra-abdominal Abscesses

Phase 3TerminatedNCT00417768

University Health Network, Toronto35 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Abscess

Interventions

Tissue Plasminogen ActivatorDRUG

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 SalineOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Intrabdominal abscess Exclusion Criteria: * Hypersensitivity to tPA * Recent stroke * Uncontrolled htn * Recent major hemorrhage * Pregnancy

Locations (1)

University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

time to eating

time to discharge

radiological evidence of resolution

Secondary Outcomes

cost comparison

Data from ClinicalTrials.gov

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