Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

NCT ID: NCT00284739

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-10-31

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 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.

Conditions

Abdominal Abscess; Pelvic Abscess

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alteplase

Multiple Alteplase injection into the abscess collection to improve percutaneous drainage

Group Type: EXPERIMENTAL

Alteplase

Intervention Type: DRUG

2mg or 4mg given twice daily for three days into loculated abscess

Saline

Multiple normal saline injection into the abscess collection to improve percutaneous drainage

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: OTHER

saline injection twice daily for three days

Interventions

Alteplase

2mg or 4mg given twice daily for three days into loculated abscess

Intervention Type: DRUG

saline

saline injection twice daily for three days

Intervention Type: OTHER

Other Intervention Names

Activase

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyo-Chun Yoon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Foundation Hospital

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

HI-03HYoon-02

Identifier Type: -

Identifier Source: org_study_id