Safety and Effectiveness of tPA in Intra-abdominal Abscesses

NCT ID: NCT00417768

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2013-11-30

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.

Conditions

Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tissue Plasminogen Activator

Intervention Type: DRUG

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.

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.

Group Type: SHAM_COMPARATOR

Normal Saline

Intervention Type: OTHER

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

Interventions

Tissue Plasminogen Activator

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.

Intervention Type: DRUG

Normal Saline

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

Intervention Type: OTHER

Other Intervention Names

Intra-abdominal drainage; tPA; Intra-abdominal abscess drain; sham arm

Eligibility Criteria

Inclusion Criteria

• Intrabdominal abscess

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dheeraj Rajan, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network - University of Toronto

Murray Asch, MD

Role: PRINCIPAL_INVESTIGATOR

Lakeridge Health Science Center

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

05-0238-E

Identifier Type: -

Identifier Source: org_study_id