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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01576679
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012

April 10, 2012
April 11, 2012
March 2012
March 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01576679 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intra-abdominal Abscess
  • Drug: Cathflo (Alteplase)
  • Drug: Saline
  • Experimental: tPA
    Intervention: Drug: Cathflo (Alteplase)
  • Placebo Comparator: Placebo
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains).
  2. Drain(s) must be inserted within the 23hrs prior to enrollment in the study.
  3. The underlying diagnosis of the condition will not affect the enrollment of the patient unless it is detailed within the exclusion criteria (section 4.1.2).
  4. Patients and parents must have signed informed consent to participate in the study.

Exclusion Criteria:1.

  1. Pancreatic abscess (not bacterial in nature)
  2. Known coagulation impairment
  3. Known central nervous system tumor or abscesses
  4. Arteriovenous malformation
  5. Aneurysm or history of central nervous system bleeding
  6. Hypersensitivity to tPA
  7. Recent administration of an investigational drug (within previous 30 days)
  8. Pregnancy
  9. Breast-feeding
  10. Fulminant hepatic failure
  11. Proven fistula (as it will alter the drainage time) or any abscess secondary to Crohn's Disease (because fistula existence cannot be excluded)
  12. Necrotizing enterocolitis
  13. Children requiring 4 or more drains
Both
up to 18 Years
No
Contact: Bairbre Connolly, MD 416-813-6034 bairbre.connolly@sickkids.ca
Canada
 
NCT01576679
1000029136
No
The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Bairbre Connolly, MD The Hospital for Sick Children
The Hospital for Sick Children
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP