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

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ClinicalTrials.gov Identifier: NCT01576679
Recruitment Status : Suspended (Slow accrual. Interim analysis)
First Posted : April 12, 2012
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Bairbre Connolly, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Intra-abdominal Abscess Drug: Cathflo (Alteplase) Drug: Saline Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : March 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess
Drug Information available for: Alteplase
U.S. FDA Resources

Arm Intervention/treatment
Experimental: tPA
tissue Plasminogen Activator
Drug: Cathflo (Alteplase)
Placebo Comparator: Placebo
Saline
Drug: Saline



Primary Outcome Measures :
  1. 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 :
  1. Documentation of any adverse event [ Time Frame: up to 2 weeks ]
  2. The length of hospital stay [ Time Frame: up to 2 months ]
  3. Rate of resolution of abscess [ Time Frame: up to 2 weeks ]
  4. Return of clinical parameters to normal [ Time Frame: up to 2 weeks ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bairbre Connolly, Project Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01576679     History of Changes
Other Study ID Numbers: 1000029136
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Abscess
Abdominal Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action