Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

Condition(s) targeted: Empyema; Pleural Effusion

Intervention: Alteplase (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: O'Brien, Jeana D., MD, FACP, FCCP

Official(s) and/or principal investigator(s):
Jeana D O'Brien, MD, FACP, FCCP, Principal Investigator, Affiliation: Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation

Overall contact:
Delores Gautier, RN, MSN, Phone: 254-724-1769, Email: lgautier@swmail.sw.org

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.

Secondary outcome:

Mortality

Hospital length of stay

Daily chest tube drainage

Radiographic improvement

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Delores Gautier, RN, MSN, Phone: 254-724-1769, Email: lgautier@swmail.sw.org

Scott and White Memorial Hospital & Clinic, Temple, Texas 76508, United States; Recruiting
Delores Gautier, RN, MSN, Phone: 254-724-1769, Email: lgautier@swmail.sw.org
Jeana D O'Brien, MD, FACP, FCCP, Principal Investigator
Dominic R deKeratry, MD, Sub-Investigator
Timothy S Mooring, MD, Sub-Investigator

Starting date: October 2004
Last updated: July 31, 2006