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Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

NCT ID: NCT00103766

Last Updated: 2006-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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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

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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.

Conditions

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Empyema Pleural Effusion

Keywords

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Alteplase Empyema Complicated Parapneumonic Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Alteplase

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Scott and White Hospital & Clinic

OTHER

Sponsor Role collaborator

Scott, Sherwood and Brindley Foundation

OTHER

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role collaborator

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

INDIV

Sponsor Role lead

Principal Investigators

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Jeana D O'Brien, MD, FACP, FCCP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Scott and White Memorial Hospital & Clinic

Temple, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Delores Gautier, RN, MSN

Role: CONTACT

Phone: 254-724-1769

Email: [email protected]

Facility Contacts

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Delores Gautier, RN, MSN

Role: primary

Other Identifiers

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8736

Identifier Type: -

Identifier Source: org_study_id