A Phase 2 interventional study of Alteplase and saline in Abdominal Abscess and Pelvic Abscess, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by Kaiser Permanente · Phase 2, Interventional, and Treatment
Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.
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.
31 studies on the registry are indexed under Abdominal Abscess; 5 are open to participants now.
This study's enrollment of 20 is below the median of 105 across 24 interventional studies indexed under Abdominal Abscess.
Browse Abdominal Abscess studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
Drug: Alteplase
Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Other: saline
2mg or 4mg given twice daily for three days into loculated abscess
Also known as: Activase
saline injection twice daily for three days
Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage
Time frame: 30 days
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.
Time frame: 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.
Time frame: Up to 30 days
Hospitalized patients with loculated abscess were enrolled
| Milestone | Alteplase | Saline |
|---|---|---|
| Started | 11 | 9 |
| Completed | 11 | 9 |
| Not completed | 0 | 0 |
| participants | Alteplase | Saline |
|---|---|---|
| Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage | 3 | 7 |
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.
| percentage of patients | Alteplase | Saline |
|---|---|---|
| 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 | 82 | 33 |
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.
| days | Alteplase | Saline |
|---|---|---|
| Duration (in Days) of Percutaneous Drainage. | 6 (4.5 to 7.5) | 11 (8 to 14) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alteplase | — | 0/11 (0%) | 0/11 (0%) |
| Saline | — | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Alteplase | Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 6 | 15 |
| >=65 years | 2 | 3 | 5 |
| Age, Continuous(years) | Alteplase | Saline | Total |
|---|---|---|---|
| Mean | 48 ± 19 | 57 ± 20 | 52 ± 20 |
| Sex: Female, Male(Participants) | Alteplase | Saline | Total |
|---|---|---|---|
| Female | 9 | 4 | 13 |
| Male | 2 | 5 | 7 |
| Region of Enrollment(participants) | Alteplase | Saline | Total |
|---|---|---|---|
| United States | 11 | 9 | 20 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tissue Plasminogen Activator