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

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Key information

Conditions

Empyema, Pleural Empyema Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pleural Effusion Respiratory Tract Diseases Respiratory Tract Infections Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Vall d'Hebron, Barcelona, Catalonia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrapleurally Alteplase vs Intrapleurally Urokinase

Drug

Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study 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

Important dates

Study start: 2003
Primary completion: 2010
Study completion: 2010
First posted: Nov 23, 2010
Registry last updated: Jul 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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