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Safety and Effectiveness of tPA in Intra-abdominal Abscesses

This study has been terminated.
(Change in patient population no longer fit study criteria.)
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: January 2, 2007
Last updated: January 13, 2014
Last verified: January 2014
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 Intervention Phase
Drug: Tissue Plasminogen Activator
Other: Normal Saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • time to eating [ Time Frame: tbd ]
  • time to discharge [ Time Frame: tbd ]
  • radiological evidence of resolution [ Time Frame: tbd ]

Secondary Outcome Measures:
  • cost comparison [ Time Frame: tbd ]

Enrollment: 35
Study Start Date: July 2005
Study Completion Date: November 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: University Health Network, Toronto Identifier: NCT00417768     History of Changes
Other Study ID Numbers: 05-0238-E
Study First Received: January 2, 2007
Last Updated: January 13, 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 processed this record on April 28, 2017