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

NCT01576679 | Terminated Phase 3 DMC

• 1 other identifier: 1000029136
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Intra-abdominal Abscess

Keywords

intra-abdominal; abscess; tPA; alteplase; cathflo

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Documentation of any adverse event

  up to 2 weeks

• The length of hospital stay

  up to 2 months

• Rate of resolution of abscess

  up to 2 weeks

• Return of clinical parameters to normal

  up to 2 weeks

Study Arms (2)

tPA

EXPERIMENTAL

tissue Plasminogen Activator

Drug: Cathflo (Alteplase)

Placebo

PLACEBO COMPARATOR

Saline

Drug: Saline

Interventions

Cathflo (Alteplase) DRUG

tPA

Saline DRUG

Placebo

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients and parents must have signed informed consent to participate in the study.
• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Abdominal Abscess; Abscess

Interventions

Tissue Plasminogen Activator; Sodium Chloride

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bairbre Connolly, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Investigator

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)