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Safety and Effectiveness of tPA in Intra-abdominal Abscesses

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00417768
First received: January 2, 2007
Last updated: September 13, 2010
Last verified: September 2010
History of Changes
  Purpose

To determine if instillation of tissue plasminogen activator into a percutaneously drained intraabdominal abscess cavity results in faster resolution of the abscess compared to normal standard of care.


Condition Intervention Phase
Abscess
 Drug: tissue plasminogen activator
 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:

Drug Information available for: Alteplase
U.S. FDA Resources

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 ]

Estimated Enrollment: 100
Study Start Date: July 2005
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: tissue plasminogen activator
    dose determined by abscess volume drained with infusion of tpa for day 0, 1 and 2 into abscess cavity
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417768

Contacts
Contact: Dheeraj Rajan, MD 416-340-4911 dheeraj.rajan@uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G2N2
Contact: Dheeraj Rajan, MD     416-340-4911     dheeraj.rajan@uhn.on.ca    
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: UHN, University of Toronto
ClinicalTrials.gov Identifier: NCT00417768     History of Changes
Other Study ID Numbers: 05-0238-E
Study First Received: January 2, 2007
Last Updated: September 13, 2010
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on June 17, 2013