Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
Information source: Kaiser Permanente
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abdominal Abscess; Pelvic Abscess
Intervention: Alteplase (Drug); saline (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Kaiser Permanente Official(s) and/or principal investigator(s): Hyo-Chun Yoon, MD, PhD, Principal Investigator, Affiliation: Kaiser Permanente Hawaii
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.
Clinical Details
Official title: Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage
Secondary outcome: Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain PlacementDuration (in Days) of Percutaneous Drainage.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Locations and Contacts
Kaiser Foundation Hospital, Honolulu, Hawaii 96819, United States
Additional Information
Starting date: February 2006
Last updated: February 24, 2015
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