Clinical Trial: Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
Brief 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.
Detailed Summary:
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 appr
Sponsor: Kaiser Permanente
Current Primary Outcome: Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage [ Time Frame: 30 days ]
Original Primary Outcome: 1. Percentage of patients requiring surgical debridement for a persistent abscess within 30 days following initial drainage
Current 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 Placement [ Time Frame: 3 days ]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.
- Duration (in Days) of Percutaneous Drainage. [ Time Frame: Up to 30 days ]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.
Original Secondary Outcome:
- 1. 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 and initiation of infusion therapy.
- 2. Duration (in days) of percutaneous drainage.
Information By: Kaiser Permanente
Dates:
Date Received: January 31, 2006
Date Started: February 2006
Date Completion:
Last Updated: February 24, 2015
Last Verified: February 2015
