Clinical Trial: Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
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 Summary: 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.
Sponsor: O'Brien, Jeana D., MD, FACP, FCCP
Current Primary Outcome: Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mortality
- Hospital length of stay
- Daily chest tube drainage
- Radiographic improvement
Original Secondary Outcome: Same as current
Information By: O'Brien, Jeana D., MD, FACP, FCCP
Dates:
Date Received: February 14, 2005
Date Started: October 2004
Date Completion:
Last Updated: July 31, 2006
Last Verified: July 2006
