Safety and Effectiveness of tPA in Intra-abdominal Abscesses

NCT00417768 | Terminated Phase 2

• 1 other identifier: 05-0238-E
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if instillation of tissue plasminogen activator into a percutaneously drained intra-abdominal abscess cavity results in faster resolution of the abscess compared to normal standard of care.

Conditions

Abscess

Keywords

tissue plasminogen activator; intraabdominal; abscess; percutaneous drainage

Outcome Measures

Primary Outcomes (3)

• time to eating

• time to discharge

• radiological evidence of resolution

Secondary Outcomes (1)

• cost comparison

Study Arms (2)

Tissue Plasminogen Activator

ACTIVE COMPARATOR

tPA administered by drainage tube into abscess, allowed to dwell for one hour and then drained into drainage bag. Dose of tPA administered to be determined by the volume of drainage immediately post drain insertion. This intervention is done on day 0, 1 and 2.

Drug: Tissue Plasminogen Activator

Instillation of Normal Saline

SHAM COMPARATOR

Insertion of abdominal drainage tube to drain intra-abdominal abscess. Normal Saline administered immediately post drain insertion. Normal Saline (10 cc) allowed to dwell for one hour, then allowed to drain into drainage bag.

Other: Normal Saline

Interventions

Tissue Plasminogen Activator DRUG

The dosage of tPA is determined by the volume of drainage obtained when abscess is first drained. The same dose will be repeated on day 1 and 2.

Also known as: Intra-abdominal drainage, tPA

Tissue Plasminogen Activator

Normal Saline OTHER

Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.

Also known as: Intra-abdominal abscess drain, sham arm

Instillation of Normal Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intrabdominal abscess

You may not qualify if:

• Hypersensitivity to tPA
• Recent stroke
• Uncontrolled htn
• Recent major hemorrhage
• Pregnancy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Abscess

Interventions

Tissue Plasminogen Activator; Saline Solution

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dheeraj Rajan, MD

  University Health Network - University of Toronto

  PRINCIPAL INVESTIGATOR

• Murray Asch, MD

  Lakeridge Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: July 1, 2005
• Primary Completion: July 1, 2012
• Study Completion: November 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

CA (1)