Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double Blind, Randomized Controlled Trial Examining the Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-abdominal Collections in Children - a Prospective Study|
- Length of time the drain remains insitu [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
The primary outcome is the length of time (in hours) the drain remains insitu.
For the primary outcome the individual abscess will be the unit of measurement; if there are multiple abscesses (up to a maximum of three) in the one patient each abscess will receive the same treatment. In the case of more than one drain being inserted in a single patient, the length of time that each drain remains in situ will be recorded individually.
- Documentation of any adverse event [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
- The length of hospital stay [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
- Rate of resolution of abscess [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
- Return of clinical parameters to normal [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
tissue Plasminogen Activator
|Drug: Cathflo (Alteplase)|
Placebo Comparator: Placebo
The use of tPA in pediatric abdominal abscesses is poorly defined. The indications are somewhat subjective and the dosage guidelines vary between institutions. Some studies have suggested that it be administered at, or soon after, the time of drainage if the ultrasound appearance of the collection is complex and/or septated, or if the initial aspirated contents are thick and viscous. Both criteria are difficult to accurately define and implement. In many instances, when there is minimal ongoing drainage despite follow-up ultrasound appearances suggesting a significant residual collection, tPA is administered several days following the initial procedure.
The purpose of this study is to establish the efficacy of tPA in the initial treatment of all pediatric intra-abdominal abcesses and a standardized manner in which it can be used. This may eventually lead to a change in practice in the management of this patient population.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576679
|Contact: Bairbre Connolly, MDfirstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G1X8|
|Contact: Simal Goman, BSc CCRP 4168137654 ext 4866 email@example.com|
|Sub-Investigator: Craig Gibson, MD|
|Sub-Investigator: Joao Amaral, MD|
|Principal Investigator:||Bairbre Connolly, MD||The Hospital for Sick Children|