Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
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ClinicalTrials.gov Identifier: NCT00103766
Recruitment Status : Unknown
Verified July 2006 by O'Brien, Jeana D., MD, FACP, FCCP. Recruitment status was: Recruiting
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.
Condition or disease
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Ability to provide written informed consent
Age greater or equal to 18 yrs
Presence of empyema or CPE
Active internal bleeding
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