Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion



Status:Recruiting
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:October 2004
Contact:Delores Gautier, RN, MSN
Email:lgautier@swmail.sw.org
Phone:254-724-1769

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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
We found this trial at
1
site
Scott and White Memorial Hospital & Clinic
Temple, Texas 76508
?
mi
from
Temple, TX
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