Safety and Effectiveness of tPA in Intra-abdominal Abscesses

University Health Network, Toronto

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Abscess

Treatments: Other: Normal Saline; Drug: Tissue Plasminogen Activator

Study type: Interventional

Funder types: Other

Identifiers

NCT00417768

05-0238-E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intrabdominal abscess

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Tissue Plasminogen Activator

Active Comparator group

Description:

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.

Treatment:

Drug: Tissue Plasminogen Activator

Instillation of Normal Saline

Sham Comparator group

Description:

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.

Treatment:

Other: Normal Saline