Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema

July 15, 2011 updated by: Hospital Universitari Vall d'Hebron Research Institute

A Prospective, Randomized, Double Blind, Controlled Trial to Evaluate Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Pleural Empyema

  1. Objectives:

    • Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema.
    • To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase
    • To evaluate the safety of alteplase in the treatment of complex complicated parapneumonic pleural effusion and empyema
  2. Design: Multicentric, randomized, parallel, controlled and double blind
  3. Main variable: Percentage of curation
  4. Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
  5. Duration of the treatment: Three days (main variable), and optional three days (secondary variable)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

204

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 5
        • Hospital Vall d'Hebron
      • LLeida, Catalunya, Spain
        • Hospital Arnau de Vilanova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Empyema and Complex Complicated Parapneumonic Pleural Effusion

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Critically illness
  • Systemic anticoagulant treatment
  • Coagulation Disorder
  • Bronchopleural fistula
  • Active bleeding
  • Recent punction of noncompressive artery
  • Stroke in the last 6 months
  • Major intervention o major traumatism in the last 6 weeks
  • Hypersensibility to urokinase or alteplase
  • Severe Liver or kidney failure
  • Inclusion in another interventional study in the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: urokinase
Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase
Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days
Active Comparator: Alteplase
Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase
Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema during one year of follow-up.
Time Frame: Evaluation at three and 6 days of treatment
It will be also an evaluation at one month, six months and one year
Evaluation at three and 6 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase
Time Frame: Evaluation at three and 6 days of treatment
Evaluation at three and 6 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Estimate)

July 18, 2011

Last Update Submitted That Met QC Criteria

July 15, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC07/90479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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