Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Empyema
- Sponsor
- O'Brien, Jeana D., MD, FACP, FCCP
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
- Last Updated
- 19 years ago
Overview
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 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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
Secondary Outcomes
- Mortality
- Hospital length of stay
- Daily chest tube drainage
- Radiographic improvement