Abdominal Abscess Clinical Trial
Official title:
Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
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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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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