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
  Purpose

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.


Condition Intervention Phase
Intra-abdominal Abscess
Drug: Cathflo (Alteplase)
Drug: Saline
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tPA Drug: Cathflo (Alteplase)
Placebo Comparator: Placebo Drug: Saline

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576679

Contacts
Contact: Bairbre Connolly, MD 416-813-6034 bairbre.connolly@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Eric Lee, BSc, MSc    4168137654 ext 4866    eric.lee@sickkids.ca   
Sub-Investigator: Craig Gibson, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Bairbre Connolly, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01576679     History of Changes
Other Study ID Numbers: 1000029136
Study First Received: April 10, 2012
Last Updated: April 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
intra-abdominal
abscess
tPA
alteplase
cathflo

Additional relevant MeSH terms:
Abscess
Abdominal Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on April 23, 2014