Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

July 31, 2006 updated by: O'Brien, Jeana D., MD, FACP, FCCP

Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.

Study Type

Interventional

Enrollment

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Temple, Texas, United States, 76508
        • Recruiting
        • Scott and White Memorial Hospital & Clinic
        • Contact:
        • Principal Investigator:
          • Jeana D O'Brien, MD, FACP, FCCP
        • Sub-Investigator:
          • Dominic R deKeratry, MD
        • Sub-Investigator:
          • Timothy S Mooring, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to provide written informed consent
  • Age greater or equal to 18 yrs
  • Presence of empyema or CPE

Exclusion Criteria:

  • Active internal bleeding
  • Pregnancy
  • Prior enrollment in this study
  • Platelet count less than 100,000/mm3
  • Use of warfarin sodium if INR is greater than 1.7
  • Use of heparin unless the PTT is less than 1.5 times baseline normal
  • Known neurological disorders
  • Current or pre-existing bleeding dyscrasia
  • Known allergy to Alteplase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.

Secondary Outcome Measures

Outcome Measure
Mortality
Hospital length of stay
Daily chest tube drainage
Radiographic improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

O'Brien, Jeana D., MD, FACP, FCCP

Collaborators

Genentech, Inc.
Texas A&M University
Scott and White Hospital & Clinic
Scott, Sherwood and Brindley Foundation

Investigators

  • Principal Investigator: Jeana D O'Brien, MD, FACP, FCCP, Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Registration Dates

First Submitted

February 14, 2005

First Submitted That Met QC Criteria

February 14, 2005

First Posted (ESTIMATE)

February 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2006

Last Update Submitted That Met QC Criteria

July 31, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8736

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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