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

Intra-abdominal Abscess Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01576679
• Other study ID #: 1000029136
• Status: Terminated
• Phase: Phase 3
• Start date: March 2012
• Est. completion date: June 2017

Study information

• Verified date: June 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Abscess
• Abscess
• Intra-abdominal Abscess

Intervention

Drug:
• Cathflo (Alteplase)

• Saline

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time the drain remains insitu	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.	up to 2 weeks
Secondary	Documentation of any adverse event		up to 2 weeks
Secondary	The length of hospital stay		up to 2 months
Secondary	Rate of resolution of abscess		up to 2 weeks
Secondary	Return of clinical parameters to normal		up to 2 weeks