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

This study has suspended participant recruitment.
(Slow accrual. Interim analysis)
Sponsor:
Information provided by (Responsible Party):
Bairbre Connolly, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01576679
First received: April 10, 2012
Last updated: May 2, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 Bairbre Connolly, The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tPA
tissue Plasminogen Activator
Drug: Cathflo (Alteplase)
Placebo Comparator: Placebo
Saline
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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Bairbre Connolly, MD The Hospital for Sick Children
  More Information

Responsible Party: Bairbre Connolly, Project Investigator, 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: May 2, 2017
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on June 23, 2017