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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00103766
Other study ID # 8736
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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