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
Sponsor:
Collaborators:
Genentech, Inc.
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
First received: February 14, 2005
Last updated: July 31, 2006
Last verified: July 2006
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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
  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:
Pleural Effusion
Empyema
Pleural Diseases
Respiratory Tract Diseases
Suppuration
Infection
Inflammation
Pathologic Processes
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 October 19, 2014