Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study
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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 |
- 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.
- 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 |
Inclusion Criteria:
- All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains).
- Drain(s) must be inserted within the 23hrs prior to enrollment in the study.
- 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).
- Patients and parents must have signed informed consent to participate in the study.
Exclusion Criteria:1.
- Pancreatic abscess (not bacterial in nature)
- Known coagulation impairment
- Known central nervous system tumor or abscesses
- Arteriovenous malformation
- Aneurysm or history of central nervous system bleeding
- Hypersensitivity to tPA
- Recent administration of an investigational drug (within previous 30 days)
- Pregnancy
- Breast-feeding
- Fulminant hepatic failure
- Proven fistula (as it will alter the drainage time) or any abscess secondary to Crohn's Disease (because fistula existence cannot be excluded)
- Necrotizing enterocolitis
- Children requiring 4 or more drains
Contacts and Locations| Contact: Bairbre Connolly, MD | 416-813-6034 | bairbre.connolly@sickkids.ca |
| 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 | |
| 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 May 23, 2013