Intra-abdominal AbscessPhase 3NCT01576679
Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study
A Phase 3 study testing Cathflo (Alteplase) and Saline in people with Intra-abdominal Abscess, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intra-abdominal Abscess
- What is being tested?
- Cathflo (Alteplase) and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Jun 2017
- Phase
- Phase 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized Controlled Trial Examining the Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-abdominal Collections in Children - a Prospective Study
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.
Read the 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.
- Conditions
- Intra-abdominal Abscess
- Being tested
- Cathflo (Alteplase), Saline
- Keywords
- intra-abdominal, abscess, tPA, alteplase, cathflo
- Medical subject headings
- Abdominal Abscess, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathflo (Alteplase)Drug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| tPA | Experimental | tissue Plasminogen Activator Receives: Drug: Cathflo (Alteplase) |
| Placebo | Placebo comparator | Saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 weeks
Secondary outcomes (4)
Documentation of any adverse event
Measured: up to 2 weeks
The length of hospital stay
Measured: up to 2 months
Rate of resolution of abscess
Measured: up to 2 weeks
Return of clinical parameters to normal
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2016
- Study completionJun 2017
Why it stopped: very slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-abdominal AbscessStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bairbre Connolly, The Hospital for Sick Children
- Investigators
- Bairbre Connolly, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576679
- Sponsor's protocol ID
- 1000029136
- Status last verified
- Jun 2019
- First submitted
- 10 Apr 2012
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized Controlled Trial Examining the Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-abdominal Collections in Children - a Prospective Study
- ClinicalTrials.gov ID
- NCT01576679
- Acronym / sponsor ID
- 1000029136
- Conditions
- Intra-abdominal Abscess
- Keywords
- intra-abdominal, abscess, tPA, alteplase, cathflo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very slow accrual.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Apr 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tPA | Experimental | Drug: Cathflo (Alteplase)tissue Plasminogen Activator |
| Placebo | Placebo comparator | Drug: SalineSaline |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Cathflo (Alteplase) | Drug | tPA |
| Saline | Drug | Placebo |
Primary outcome
Length of time the drain remains insitu
Time frame: up to 2 weeks
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.
4 secondary outcomes
Documentation of any adverse event
Time frame: up to 2 weeks
The length of hospital stay
Time frame: up to 2 months
Rate of resolution of abscess
Time frame: up to 2 weeks
Return of clinical parameters to normal
Time frame: up to 2 weeks
Results and safety
The study was stopped early (reason given: very slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Bairbre Connolly, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cathflo (Alteplase) and Saline in people with Intra-abdominal Abscess, run by The Hospital for Sick Children 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 4 inclusion and 13 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 27 Jun 2019. 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 phase mean?
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: very slow accrual.). 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?
Length of time the drain remains insitu (time frame: up to 2 weeks). 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 27 Jun 2019.