Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00284739
First received: January 31, 2006
Last updated: February 24, 2015
Last verified: February 2015
  Purpose

Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.


Condition Intervention Phase
Abdominal Abscess
Pelvic Abscess
Drug: Alteplase
Other: saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: February 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alteplase
Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
Drug: Alteplase
2mg or 4mg given twice daily for three days into loculated abscess
Other Name: Activase
Placebo Comparator: Saline
Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Other: saline
saline injection twice daily for three days

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284739

Locations
United States, Hawaii
Kaiser Foundation Hospital
Honolulu, Hawaii, United States, 96819
Sponsors and Collaborators
Kaiser Permanente
Genentech, Inc.
Investigators
Principal Investigator: Hyo-Chun Yoon, MD, PhD Kaiser Permanente Hawaii
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00284739     History of Changes
Other Study ID Numbers: HI-03HYoon-02
Study First Received: January 31, 2006
Results First Received: December 16, 2013
Last Updated: February 24, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Abdominal Abscess
Abscess
Infection
Inflammation
Pathologic Processes
Suppuration
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015