Abdominal AbscessPhase 2NCT00284739
Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
A Phase 2 study testing Alteplase and saline in people with Abdominal Abscess and Pelvic Abscess, run by Kaiser Permanente at 1 site in United States.
Trial summary
Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Abscess, Pelvic Abscess
- What is being tested?
- Alteplase and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Oct 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age > 18 years
- Adult, non-gravid patients with loculated abdominopelvic abscesses immediately after percutaneous drainage will be eligible to participate. A loculated abscess is defined as an abscess whose contents cannot be completely drained at the time of initial catheter placement as documented on CT.
Who cannot join
- Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
- History of stroke within 6 months
- Uncorrectable bleeding diathesis (INR > 1.3 despite therapy)
- Recent intracranial or intraspinal surgery or trauma
- Pregnancy (positive pregnancy test)
- Pancreatic abscesses
Show all 11Show fewer
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Participation in another clinical investigation within previous 30 days of catheter placement
- Prior enrollment in the study
- Known allergy to Alteplase or any of its components
Trial locations and contacts
1 site in 1 country.
About this study
Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.
Read the detailed description
The use of fibrinolytics for the percutaneous drainage of loculated pleural effusions has been shown to reduce the catheter dwell time and to improve drainage of the effusions. Abscesses in the abdomen and pelvis are often loculated which makes percutaneous drainage difficult. We hypothesize that the infusion of alteplase via a drainage catheter into the loculated abscess collections of the abdomen and pelvis will similarly decrease catheter dwell time and improve overall abscess drainage. The direct injection of Activase into abscess cavities utilizes a very low dose of drug within a closed environment which should not be associated with any significant risk of hemorrhage. To date, there does not appear to be a significant risk of systemic hemorrhagic complications associated with the use of intracavitary thrombolytics for the drainage of abdominopelvic abscesses although only a few such studies have been reported. We hope to prove that the use alteplase for intracavitary thrombolysis improves outcomes associated with percutaneous catheter drainage of loculated abscess collections without increasing complications or costs.
The design of the trial will be as a single-center, prospective, open-label, randomized trial comparing the infusion of Activase versus saline for treatment of loculated abdominopelvic abscesses requiring percutaneous drainage. Patients with loculated abdominopelvic abscesses who are referred for percutaneous drainage will be eligible for this study. Patients will undergo standard placement of a 10-12 french percutaneous drain into their abscess cavity under computed tomography guidance. If the entire contents of the abscess cavity cannot be aspirated at the time of initial catheter placement, the abscess will be assumed to be loculated. The patient will then be randomized to have their abscess catheter irrigated twice a day with a volume of fluid approximately equal to the one-half the residual volume of the abscess. In the control group, the normal saline will be fluid instilled into the abscess cavity. The study group will receive Activase reconstituted in sterile water and then diluted to the appropriate volume with normal saline.
- Conditions
- Abdominal Abscess, Pelvic Abscess
- Being tested
- Alteplase, saline
- Medical subject headings
- Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
Also called Activase
2mg or 4mg given twice daily for three days into loculated abscess
salineOther
saline injection twice daily for three days
| Study group | Role | What they receive |
|---|---|---|
| Alteplase | Experimental | Multiple Alteplase injection into the abscess collection to improve percutaneous drainage Receives: Drug: Alteplase |
| Saline | Placebo comparator | Multiple normal saline injection into the abscess collection to improve percutaneous drainage Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage
Measured: 30 days
Secondary outcomes (2)
Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement
This is the percentage of participants in whom their loculated abscess completely resolve with percutaneous drainage at the time of the first followup CT performed at 3 days after start of the intervention and therefore do NOT require additional surgical intervention.
Measured: 3 days
Duration (in Days) of Percutaneous Drainage.
The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal AbscessStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Hyo-Chun Yoon, MD, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284739
- Sponsor's protocol ID
- HI-03HYoon-02
- Status last verified
- Feb 2015
- First submitted
- 31 Jan 2006
- Last updated
- 26 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
- ClinicalTrials.gov ID
- NCT00284739
- Acronym / sponsor ID
- HI-03HYoon-02
- Conditions
- Abdominal Abscess, Pelvic Abscess
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 1 Feb 2006 (estimated)
- Results
- Posted 26 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.
Detailed description
The use of fibrinolytics for the percutaneous drainage of loculated pleural effusions has been shown to reduce the catheter dwell time and to improve drainage of the effusions. Abscesses in the abdomen and pelvis are often loculated which makes percutaneous drainage difficult. We hypothesize that the infusion of alteplase via a drainage catheter into the loculated abscess collections of the abdomen and pelvis will similarly decrease catheter dwell time and improve overall abscess drainage. The direct injection of Activase into abscess cavities utilizes a very low dose of drug within a closed environment which should not be associated with any significant risk of hemorrhage. To date, there does not appear to be a significant risk of systemic hemorrhagic complications associated with the use of intracavitary thrombolytics for the drainage of abdominopelvic abscesses although only a few such studies have been reported. We hope to prove that the use alteplase for intracavitary thrombolysis improves outcomes associated with percutaneous catheter drainage of loculated abscess collections without increasing complications or costs.
The design of the trial will be as a single-center, prospective, open-label, randomized trial comparing the infusion of Activase versus saline for treatment of loculated abdominopelvic abscesses requiring percutaneous drainage. Patients with loculated abdominopelvic abscesses who are referred for percutaneous drainage will be eligible for this study. Patients will undergo standard placement of a 10-12 french percutaneous drain into their abscess cavity under computed tomography guidance. If the entire contents of the abscess cavity cannot be aspirated at the time of initial catheter placement, the abscess will be assumed to be loculated. The patient will then be randomized to have their abscess catheter irrigated twice a day with a volume of fluid approximately equal to the one-half the residual volume of the abscess. In the control group, the normal saline will be fluid instilled into the abscess cavity. The study group will receive Activase reconstituted in sterile water and then diluted to the appropriate volume with normal saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alteplase | Experimental | Drug: AlteplaseMultiple Alteplase injection into the abscess collection to improve percutaneous drainage |
| Saline | Placebo comparator | Other: salineMultiple normal saline injection into the abscess collection to improve percutaneous drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age > 18 years
- Adult, non-gravid patients with loculated abdominopelvic abscesses immediately after percutaneous drainage will be eligible to participate. A loculated abscess is defined as an abscess whose contents cannot be completely drained at the time of initial catheter placement as documented on CT.
Key exclusion criteria (11 listed)
- Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
- History of stroke within 6 months
- Uncorrectable bleeding diathesis (INR > 1.3 despite therapy)
- Recent intracranial or intraspinal surgery or trauma
- Pregnancy (positive pregnancy test)
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 |
|---|---|---|
| AlteplaseAlso: Activase2mg or 4mg given twice daily for three days into loculated abscess | Drug | Alteplase |
| salinesaline injection twice daily for three days | Other | Saline |
Primary outcome
Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage
Time frame: 30 days
2 secondary outcomes
Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement
Time frame: 3 days
Duration (in Days) of Percutaneous Drainage.
Time frame: Up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hyo-Chun Yoon, MD, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alteplase and saline in people with Abdominal Abscess and Pelvic Abscess, run by Kaiser Permanente at 1 site in United States.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 26 Feb 2015. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage (time frame: 30 days). 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 26 Feb 2015.