Back to resultsAlteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Primary Purpose
Empyema, Pleural Effusion
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alteplase
Sponsored by
About this trial
This is an interventional treatment trial for Empyema focused on measuring Alteplase, Empyema, Complicated Parapneumonic Effusion
Eligibility Criteria
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
Sites / Locations
- Scott and White Memorial Hospital & ClinicRecruiting
Outcomes
Primary Outcome Measures
Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
Secondary Outcome Measures
Mortality
Hospital length of stay
Daily chest tube drainage
Radiographic improvement
Full Information
NCT ID
NCT00103766
First Posted
February 14, 2005
Last Updated
July 31, 2006
Sponsor
O'Brien, Jeana D., MD, FACP, FCCP
Collaborators
Genentech, Inc., Scott and White Hospital & Clinic, Scott, Sherwood and Brindley Foundation, Texas A&M University
1. Study Identification
Unique Protocol Identification Number
NCT00103766
Brief Title
Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Official Title
Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
O'Brien, Jeana D., MD, FACP, FCCP
Collaborators
Genentech, Inc., Scott and White Hospital & Clinic, Scott, Sherwood and Brindley Foundation, Texas A&M University
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Empyema, Pleural Effusion
Keywords
Alteplase, Empyema, Complicated Parapneumonic Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alteplase
Primary Outcome Measure Information:
Title
Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
Secondary Outcome Measure Information:
Title
Mortality
Title
Hospital length of stay
Title
Daily chest tube drainage
Title
Radiographic improvement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Delores Gautier, RN, MSN
Phone
254-724-1769
Email
lgautier@swmail.sw.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeana D O'Brien, MD, FACP, FCCP
Organizational Affiliation
Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scott and White Memorial Hospital & Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delores Gautier, RN, MSN
Phone
254-724-1769
Email
lgautier@swmail.sw.org
First Name & Middle Initial & Last Name & Degree
Jeana D O'Brien, MD, FACP, FCCP
First Name & Middle Initial & Last Name & Degree
Dominic R deKeratry, MD
First Name & Middle Initial & Last Name & Degree
Timothy S Mooring, MD
12. IPD Sharing Statement
Learn more about this trial
Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
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