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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alteplase | Experimental | Multiple Alteplase injection into the abscess collection to improve percutaneous drainage |
|
| Saline | Placebo Comparator | Multiple normal saline injection into the abscess collection to improve percutaneous drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase | Drug | 2mg or 4mg given twice daily for three days into loculated abscess |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo-Chun Yoon, MD, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Foundation Hospital | Honolulu | Hawaii | 96819 | United States |
All patients had undergone percutaneous drainage for abscess and loculation documented by residual fluid surrounding the catheter after initial drainage
Hospitalized patients with loculated abscess were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Alteplase | Multiple Alteplase injection into the abscess collection to improve percutaneous drainage |
| FG001 | Saline | Multiple normal saline injection into the abscess collection to improve percutaneous drainage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alteplase | Multiple Alteplase injection into the abscess collection to improve percutaneous drainage |
| BG001 | Saline | Multiple normal saline injection into the abscess collection to improve percutaneous drainage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage | Posted | Number | participants | 30 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alteplase | Multiple Alteplase injection into the abscess collection to improve percutaneous drainage |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hyo-Chun Yoon, MD,PHD | Kaiser Permanente | 8084327342 | Hyo-Chun.Yoon@nsmtp.kp.org |
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| ID | Term |
|---|---|
| D018784 | Abdominal Abscess |
| ID | Term |
|---|---|
| D000038 | Abscess |
| D013492 | Suppuration |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| saline | Other | saline injection twice daily for three days |
|
| 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. | Up to 30 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Number | percentage of patients | 3 days |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | days | Up to 30 days |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Saline | Multiple normal saline injection into the abscess collection to improve percutaneous drainage | 0 | 9 | 0 | 9 |
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| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |