AbscessPhase 2/3NCT00417768
Safety and Effectiveness of tPA in Intra-abdominal Abscesses
A Phase 2/3 study testing Tissue Plasminogen Activator and Normal Saline in people with Abscess, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abscess
- What is being tested?
- Tissue Plasminogen Activator and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to Nov 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intrabdominal abscess
Who cannot join
- Hypersensitivity to tPA
- Recent stroke
- Uncontrolled htn
- Recent major hemorrhage
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Abscess
- Being tested
- Tissue Plasminogen Activator, Normal Saline
- Keywords
- tissue plasminogen activator, intraabdominal, abscess, percutaneous drainage
- Medical subject headings
- Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Plasminogen ActivatorDrug
Also called Intra-abdominal drainage, tPA
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.
Normal SalineOther
Also called Intra-abdominal abscess drain, sham arm
Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to eating
time to discharge
radiological evidence of resolution
Secondary outcomes (1)
cost comparison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startJul 2005
- Primary completionJul 2012
- Study completionNov 2013
Why it stopped: Change in patient population no longer fit study criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbscessStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dheeraj Rajan, MD, Principal investigator, University Health Network - University of TorontoMurray Asch, MD, Principal investigator, Lakeridge Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417768
- Sponsor's protocol ID
- 05-0238-E
- Status last verified
- Jan 2014
- First submitted
- 2 Jan 2007
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00417768
- Acronym / sponsor ID
- 05-0238-E
- Conditions
- Abscess
- Keywords
- tissue plasminogen activator, intraabdominal, abscess, percutaneous drainage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in patient population no longer fit study criteria.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue Plasminogen Activator | Active comparator | Drug: Tissue Plasminogen ActivatortPA 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. |
| Instillation of Normal Saline | Sham comparator | Other: Normal SalineInsertion 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intrabdominal abscess
Key exclusion criteria (5 listed)
- Hypersensitivity to tPA
- Recent stroke
- Uncontrolled htn
- Recent major hemorrhage
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Plasminogen ActivatorAlso: Intra-abdominal drainage, tPAThe 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. | Drug | Tissue Plasminogen Activator |
| Normal SalineAlso: Intra-abdominal abscess drain, sham armNormal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm. | Other | Instillation of Normal Saline |
Primary outcome
time to eating
time to discharge
radiological evidence of resolution
1 secondary outcome
cost comparison
Results and safety
The study was stopped early (reason given: Change in patient population no longer fit study criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dheeraj Rajan, MD principal investigator
University Health Network - University of Toronto
Murray Asch, MD principal investigator
Lakeridge Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tissue Plasminogen Activator and Normal Saline in people with Abscess, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change in patient population no longer fit study criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to eating. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.