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NCT00417768 Clinical Trial

Safety and Effectiveness of tPA in Intra-abdominal Abscesses

Abscess Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00417768
Other study ID # 05-0238-E
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received January 2, 2007
Last updated January 13, 2014
Start date July 2005
Est. completion date November 2013

Study information
Verified date January 2014
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 35
Est. completion date November 2013
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Intrabdominal abscess

Exclusion Criteria:

- Hypersensitivity to tPA

- Recent stroke

- Uncontrolled htn

- Recent major hemorrhage

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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:
• Normal Saline
Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.

Locations
Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to eating tbd No
Primary time to discharge tbd No
Primary radiological evidence of resolution tbd No
Secondary cost comparison tbd No
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