Clinical Trial: Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

Brief Summary: The objective of this study is to establish the efficacy of tPA when used in pediatric intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the ultrasound appearance or consistency of the drained fluid.

Detailed Summary:

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.


Sponsor: The Hospital for Sick Children

Current Primary Outcome: Length of time the drain remains insitu [ Time Frame: up to 2 weeks ]

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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Documentation of any adverse event [ Time Frame: up to 2 weeks ]
  • The length of hospital stay [ Time Frame: up to 2 months ]
  • Rate of resolution of abscess [ Time Frame: up to 2 weeks ]
  • Return of clinical parameters to normal [ Time Frame: up to 2 weeks ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: April 10, 2012
Date Started: March 2012
Date Completion: December 2017
Last Updated: May 2, 2017
Last Verified: May 2017