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Safety and Effectiveness of tPA in Intra-abdominal Abscesses

Primary Purpose

Abscess

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Tissue Plasminogen Activator
Normal Saline
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring tissue plasminogen activator, intraabdominal, abscess, percutaneous drainage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Intrabdominal abscess

Exclusion Criteria:

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

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Tissue Plasminogen Activator

Instillation of Normal Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

time to eating
time to discharge
radiological evidence of resolution

Secondary Outcome Measures

cost comparison

Full Information

First Posted
January 2, 2007
Last Updated
January 13, 2014
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00417768
Brief Title
Safety and Effectiveness of tPA in Intra-abdominal Abscesses
Official Title
Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Change in patient population no longer fit study criteria.
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
On day 0 Subjects will have Tissue Plasminogen Activator injected into a drainage tube and allowed to dwell in the intra-abdominal abscess for one hour before allowing it to drain by gravity. This will be repeated on day 1 and 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
tissue plasminogen activator, intraabdominal, abscess, percutaneous drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tissue Plasminogen Activator
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Instillation of Normal Saline
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tissue Plasminogen Activator
Other Intervention Name(s)
Intra-abdominal drainage, tPA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Intra-abdominal abscess drain, sham arm
Intervention Description
Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.
Primary Outcome Measure Information:
Title
time to eating
Title
time to discharge
Title
radiological evidence of resolution
Secondary Outcome Measure Information:
Title
cost comparison

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intrabdominal abscess Exclusion Criteria: Hypersensitivity to tPA Recent stroke Uncontrolled htn Recent major hemorrhage Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dheeraj Rajan, MD
Organizational Affiliation
University Health Network - University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murray Asch, MD
Organizational Affiliation
Lakeridge Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Safety and Effectiveness of tPA in Intra-abdominal Abscesses

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