Recruiting

Alteplase

Sponsor:

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

Code:

NCT00103766

Conditions

Empyema

Pleural Effusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Alteplase

Study Details

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.

Conditions

Empyema

Pleural Effusion

Study ID

NCT00103766

Start date

Oct, 2004

Status verified date

Jul, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Alteplase

Primary outcome measure

  • Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Delores Gautier, RN, MSN

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

Locations

Scott and White Memorial Hospital & Clinic

Recruiting

Temple, Texas, United States, 76508

Contacts

Delores Gautier, RN, MSN

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

Principal Investigator:

Jeana D O'Brien, MD, FACP, FCCP

More Information

Sponsor

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

Last update posted

Aug 1, 2006

Last verified

Jul, 2006

Keywords

  • Alteplase
  • Empyema
  • Complicated Parapneumonic Effusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by O'Brien, Jeana D., MD, FACP, FCCP on 2006-08-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.