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

Primary Purpose

Intra-abdominal Abscess

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Cathflo (Alteplase)

Saline

About this trial

This is an interventional treatment trial for Intra-abdominal Abscess focused on measuring intra-abdominal, abscess, tPA, alteplase, cathflo

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tPA

Placebo

Arm Description

tissue Plasminogen Activator

Saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Documentation of any adverse event

The length of hospital stay

Rate of resolution of abscess

Return of clinical parameters to normal

Full Information

NCT ID

NCT01576679

First Posted

April 10, 2012

Last Updated

June 25, 2019

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT01576679

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

very slow accrual.

Study Start Date

March 2012 (Actual)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intra-abdominal Abscess

Keywords

intra-abdominal, abscess, tPA, alteplase, cathflo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tPA

Arm Type

Experimental

Arm Description

tissue Plasminogen Activator

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline

Intervention Type

Drug

Intervention Name(s)

Cathflo (Alteplase)

Intervention Type

Drug

Intervention Name(s)

Saline

Primary Outcome Measure Information:

Title

Length of time the drain remains insitu

Description

Time Frame

up to 2 weeks

Secondary Outcome Measure Information:

Title

Documentation of any adverse event

Time Frame

up to 2 weeks

Title

The length of hospital stay

Time Frame

up to 2 months

Title

Rate of resolution of abscess

Time Frame

up to 2 weeks

Title

Return of clinical parameters to normal

Time Frame

up to 2 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bairbre Connolly, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G1X8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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