Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00103766
• Other study ID #: 8736
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2005
• Last updated: July 31, 2006
• Start date: October 2004

Study information

• Verified date: July 2006
• Source: O'Brien, Jeana D., MD, FACP, FCCP
• Contact: Delores Gautier, RN, MSN
• Phone: 254-724-1769
• Email: lgautier[@]swmail.sw.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Empyema
• Pleural Effusion

Intervention

Drug:
• Alteplase

Locations

Country	Name	City	State
United States	Scott and White Memorial Hospital & Clinic	Temple	Texas

Sponsors (5)

Lead Sponsor	Collaborator
O'Brien, Jeana D., MD, FACP, FCCP	Genentech, Inc., Scott and White Hospital & Clinic, Scott, Sherwood and Brindley Foundation, Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
Secondary	Mortality
Secondary	Hospital length of stay
Secondary	Daily chest tube drainage
Secondary	Radiographic improvement