Safety and Efficacy of the Use of Tissue Plasminogen Acti... | NCT01576679

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

NCT01576679

Sponsor

The Hospital for Sick Children

Status

Terminated

Last Update Posted

Jun 27, 2019Actual

Enrollment

28Actual

Phase

Phase 3

Conditions

Intra-abdominal Abscess

Interventions

Cathflo (Alteplase)
Saline

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

very slow accrual.

Expanded Access Info

Start Date

Mar 2012Actual

Primary Completion Date

May 2016Actual

Completion Date

Jun 2017Actual

First Submitted Date

Apr 10, 2012

First Submission Date that Met QC Criteria

Apr 11, 2012

First Posted Date

Apr 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2019

Last Update Posted Date

Jun 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tPA	Experimental	tissue Plasminogen Activator	Drug: Cathflo (Alteplase)
Placebo	Placebo Comparator	Saline	Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cathflo (Alteplase)	Drug		tPA
Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Documentation of any adverse event		up to 2 weeks
The length of hospital stay		up to 2 months
Rate of resolution of abscess

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bairbre Connolly, MD	The Hospital for Sick Children	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G1X8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018784	Abdominal Abscess
D000038	Abscess

Ancestor Terms

ID	Term
D013492	Suppuration
D007239	Infections
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010959	Tissue Plasminogen Activator
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided