Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2006 by O'Brien, Jeana D., MD, FACP, FCCP. Recruitment status was Recruiting

First Received on February 14, 2005. Last Updated on July 31, 2006 History of Changes

Sponsor:	O'Brien, Jeana D., MD, FACP, FCCP
Collaborators:	Genentech Scott and White Hospital & Clinic Scott, Sherwood and Brindley Foundation Texas A&M University
Information provided by:	O'Brien, Jeana D., MD, FACP, FCCP
ClinicalTrials.gov Identifier:	NCT00103766

Purpose

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	Intervention
Empyema Pleural Effusion	Drug: Alteplase

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

Resource links provided by NLM:

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

Further study details as provided by O'Brien, Jeana D., MD, FACP, FCCP:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Mortality
Hospital length of stay
Daily chest tube drainage
Radiographic improvement

Estimated Enrollment:	75
Study Start Date:	October 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103766

Contacts

Contact: Delores Gautier, RN, MSN

254-724-1769

lgautier@swmail.sw.org

Locations

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

Sponsors and Collaborators

O'Brien, Jeana D., MD, FACP, FCCP

Genentech

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00103766 History of Changes
Other Study ID Numbers:	8736
Study First Received:	February 14, 2005
Last Updated:	July 31, 2006
Health Authority:	United States: Food and Drug Administration

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

Alteplase
Empyema
Complicated Parapneumonic Effusion

Additional relevant MeSH terms:

Empyema
Pleural Effusion
Suppuration
Infection
Inflammation
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases

Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012