Safety and Effectiveness of tPA in Intra-abdominal Abscesses

January 13, 2014 updated by: University Health Network, Toronto

Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intrabdominal abscess

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Other Names:
  • tPA
  • Intra-abdominal drainage
Sham Comparator: 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.
Other: Normal Saline
Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.
Other Names:
  • Intra-abdominal abscess drain
  • sham arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
time to eating
time to discharge
radiological evidence of resolution

Secondary Outcome Measures

Outcome Measure
cost comparison

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Dheeraj Rajan, MD, University Health Network - University of Toronto
  • Principal Investigator: Murray Asch, MD, Lakeridge Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-0238-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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