Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

• Sponsor: O'Brien, Jeana D., MD, FACP, FCCP (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00103766
• Collaborator: Genentech, Inc. (Industry), Scott and White Hospital & Clinic (Other), Scott, Sherwood and Brindley Foundation (Other), Texas A&M University (Other)
• Enrollment: 75
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Empyema; Pleural Effusion	Drug: Alteplase	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
• Study Start Date: Oct 1, 2004

Outcome Measures

Primary Outcome Measures

1. Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy. []

Secondary Outcome Measures

1. Mortality []

2. Hospital length of stay []

3. Daily chest tube drainage []

4. Radiographic improvement []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scott and White Memorial Hospital & Clinic	Temple	Texas	United States	76508

Sponsors and Collaborators

• O'Brien, Jeana D., MD, FACP, FCCP
• Genentech, Inc.
• Scott and White Hospital & Clinic
• Scott, Sherwood and Brindley Foundation
• Texas A&M University

Investigators

• Principal Investigator: Jeana D O'Brien, MD, FACP, FCCP, Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00103766
• Other Study ID Numbers: 8736
• First Posted: Feb 15, 2005
• Last Update Posted: Aug 1, 2006
• Last Verified: Jul 1, 2006

• Keywords provided by , ,: Alteplase; Empyema; Complicated Parapneumonic Effusion
• Additional relevant MeSH terms: Empyema; Pleural Effusion; Tissue Plasminogen Activator

Study Results

No Results Posted as of Aug 1, 2006