NCT00103766

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2005

Completed
Last Updated

August 1, 2006

Status Verified

July 1, 2006

First QC Date

February 14, 2005

Last Update Submit

July 31, 2006

Conditions

EmpyemaPleural Effusion

Keywords

AlteplaseEmpyemaComplicated Parapneumonic Effusion

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • Mortality

  • Hospital length of stay

  • Daily chest tube drainage

  • Radiographic improvement

Interventions

AlteplaseDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide written informed consent
  • Age greater or equal to 18 yrs
  • Presence of empyema or CPE

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scott and White Memorial Hospital & Clinic

Temple, Texas, 76508, United States

RECRUITING

MeSH Terms

Conditions

EmpyemaPleural Effusion

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Jeana D O'Brien, MD, FACP, FCCP

    Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Delores Gautier, RN, MSN

CONTACT

254-724-1769lgautier@swmail.sw.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

February 14, 2005

First Posted

February 15, 2005

Study Start

October 1, 2004

Last Updated

August 1, 2006

Record last verified: 2006-07

Locations

US(1)