Safety and Effectiveness of tPA in Intra-abdominal Abscesses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00417768|
Recruitment Status : Terminated (Change in patient population no longer fit study criteria.)
First Posted : January 4, 2007
Last Update Posted : January 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Abscess||Drug: Tissue Plasminogen Activator Other: Normal Saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
|Study Start Date :||July 2005|
|Primary Completion Date :||July 2012|
|Study Completion Date :||November 2013|
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.
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.
- time to eating
- time to discharge
- radiological evidence of resolution
- cost comparison
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417768
|University Health Network|
|Toronto, Ontario, Canada|
|Principal Investigator:||Dheeraj Rajan, MD||University Health Network - University of Toronto|
|Principal Investigator:||Murray Asch, MD||Lakeridge Health Science Center|