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
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 2, 2007 | ||||||||
| Last Updated Date | September 13, 2010 | ||||||||
| Start Date ICMJE | July 2005 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00417768 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
cost comparison [ Time Frame: tbd ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
cost comparison | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Effectiveness of tPA in Intra-abdominal Abscesses | ||||||||
| Official Title ICMJE | Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
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| Condition ICMJE | Abscess | ||||||||
| Intervention ICMJE | Drug: tissue plasminogen activator
dose determined by abscess volume drained with infusion of tpa for day 0, 1 and 2 into abscess cavity |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00417768 | ||||||||
| Other Study ID Numbers ICMJE | 05-0238-E | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | UHN, University of Toronto | ||||||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||||||
| Verification Date | September 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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