Trial | NCT00103766  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    alteplase ...

  • Study Participants

    75
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.
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.
Study Started
Oct 31
2004
Last Update
Aug 01
2006
Estimate

Drug Alteplase

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
No Results Posted