Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

NCT00284739 | Completed Phase 2 Results

• 1 other identifier: HI-03HYoon-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Abscess; Pelvic Abscess

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage

  30 days

Secondary Outcomes (2)

• 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

  3 days

• Duration (in Days) of Percutaneous Drainage.

  Up to 30 days

Study Arms (2)

Alteplase

EXPERIMENTAL

Multiple Alteplase injection into the abscess collection to improve percutaneous drainage

Drug: Alteplase

Saline

PLACEBO COMPARATOR

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

Other: saline

Interventions

Alteplase DRUG

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

Also known as: Activase

Alteplase

saline OTHER

saline injection twice daily for three days

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Kaiser Foundation Hospital

Honolulu, Hawaii, 96819, United States

Location

MeSH Terms

Conditions

Abdominal Abscess

Interventions

Tissue Plasminogen Activator; Sodium Chloride

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Hyo-Chun Yoon, MD,PHD
• Organization: Kaiser Permanente

Hyo-Chun.Yoon@nsmtp.kp.org

8084327342

Study Officials

• Hyo-Chun Yoon, MD, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 1, 2006
• Study Start: February 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 26, 2015
• Results First Posted: February 26, 2015

Record last verified: 2015-02

Locations

US (1)