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

Primary Purpose

Empyema, Pleural, Pleural Effusion, Pleural Diseases

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Intrapleurally Alteplase vs Intrapleurally Urokinase
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Empyema, Pleural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Vall d'Hebron
  • Hospital Arnau de Vilanova

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

urokinase

Alteplase

Arm Description

Outcomes

Primary Outcome Measures

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.
It will be also an evaluation at one month, six months and one year

Secondary Outcome Measures

To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase

Full Information

First Posted
November 18, 2010
Last Updated
July 15, 2011
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01246453
Brief Title
Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 Design: Multicentric, randomized, parallel, controlled and double blind Main variable: Percentage of curation Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema Duration of the treatment: Three days (main variable), and optional three days (secondary variable)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Empyema, Pleural, Pleural Effusion, Pleural Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
urokinase
Arm Type
Active Comparator
Arm Title
Alteplase
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Intrapleurally Alteplase vs Intrapleurally Urokinase
Intervention Description
Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days
Primary Outcome Measure Information:
Title
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.
Description
It will be also an evaluation at one month, six months and one year
Time Frame
Evaluation at three and 6 days of treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Vall d'Hebron
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
5
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
LLeida
State/Province
Catalunya
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26423784
Citation
Aleman C, Porcel JM, Alegre J, Ruiz E, Bielsa S, Andreu J, Deu M, Sune P, Martinez-Sogues M, Lopez I, Pallisa E, Schoenenberger JA, Bruno Montoro J, de Sevilla TF. Intrapleural Fibrinolysis with Urokinase Versus Alteplase in Complicated Parapneumonic Pleural Effusions and Empyemas: A Prospective Randomized Study. Lung. 2015 Dec;193(6):993-1000. doi: 10.1007/s00408-015-9807-6. Epub 2015 Sep 30.
Results Reference
derived

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

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