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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.)
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00417768
First received: January 2, 2007
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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
Abscess
Drug: Tissue Plasminogen Activator
Other: Normal Saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]
  • time to discharge [ Time Frame: tbd ] [ Designated as safety issue: No ]
  • radiological evidence of resolution [ Time Frame: tbd ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cost comparison [ Time Frame: tbd ] [ Designated as safety issue: No ]

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
  • normal saline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intrabdominal abscess

Exclusion Criteria:

  • Hypersensitivity to tPA
  • Recent stroke
  • Uncontrolled htn
  • Recent major hemorrhage
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417768

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00417768     History of Changes
Other Study ID Numbers: 05-0238-E
Study First Received: January 2, 2007
Last Updated: January 13, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Abscess
Infection
Inflammation
Pathologic Processes
Suppuration
Plasminogen
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014