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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 4

Conditions: Empyema, Pleural; Pleural Effusion; Pleural Diseases

Treatments: Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

Study type: Interventional

Funder types: Other

Identifiers

NCT01246453

EC07/90479

Details and patient eligibility

About

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)

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 2 patient groups

urokinase

Active Comparator group

Treatment:

Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

Alteplase

Active Comparator group

Treatment:

Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase