Safety and Effectiveness of tPA in Intra-Abdominal Abscesses

This study is currently recruiting participants.

Verified by University Health Network, Toronto, June 2008

First Received: January 2, 2007 Last Updated: February 12, 2009 History of Changes

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00417768

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study
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 Tissue-type plasminogen activator

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:

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:	University of Toronto ( UHN )
Study ID Numbers:	05-0238-E
Study First Received:	January 2, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00417768 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

tissue plasminogen activator
intraabdominal
abscess
percutaneous drainage

Study placed in the following topic categories:

Abdominal Abscess
Fibrin Modulating Agents
Abscess
Tissue Plasminogen Activator
Suppuration

Fibrinolytic Agents
Cardiovascular Agents
Plasminogen
Inflammation

Additional relevant MeSH terms:

Abdominal Abscess
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Tissue Plasminogen Activator
Fibrinolytic Agents
Cardiovascular Agents
Infection
Pharmacologic Actions

Inflammation
Fibrin Modulating Agents
Pathologic Processes
Therapeutic Uses
Abscess
Suppuration
Plasminogen

ClinicalTrials.gov processed this record on September 11, 2009