Safety and Effectiveness of tPA in Intra-abdominal Abscesses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417768
Recruitment Status : Terminated (Change in patient population no longer fit study criteria.)
First Posted : January 4, 2007
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Abscess Drug: Tissue Plasminogen Activator Other: Normal Saline Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial
Study Start Date : July 2005
Actual Primary Completion Date : July 2012
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess
Drug Information available for: Alteplase
U.S. FDA Resources

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:
  • Intra-abdominal drainage
  • tPA
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

Primary Outcome Measures :
  1. time to eating
  2. time to discharge
  3. radiological evidence of resolution

Secondary Outcome Measures :
  1. cost comparison

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Intrabdominal abscess

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417768

Canada, Ontario
University Health Network
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Dheeraj Rajan, MD University Health Network - University of Toronto
Principal Investigator: Murray Asch, MD Lakeridge Health Science Center

Responsible Party: University Health Network, Toronto Identifier: NCT00417768     History of Changes
Other Study ID Numbers: 05-0238-E
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by University Health Network, Toronto:
tissue plasminogen activator
percutaneous drainage

Additional relevant MeSH terms:
Pathologic Processes
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action