Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00103766

Enrollment

Registered

2005-02-15

Start date

2004-10-31

Completion date

Unknown

Last updated

2006-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empyema, Pleural Effusion

Keywords

Alteplase, Empyema, Complicated Parapneumonic Effusion

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.

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.

Interventions

DRUGAlteplase

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Mortality	—
Hospital length of stay	—
Daily chest tube drainage	—
Radiographic improvement	—

Countries

United States

Contacts

Primary ContactDelores Gautier, RN, MSN

lgautier@swmail.sw.org254-724-1769

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026