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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01246453

Enrollment

204

Registered

2010-11-23

Start date

2003-12-31

Completion date

2010-12-31

Last updated

2011-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empyema, Pleural, Pleural Diseases, Pleural Effusion

Brief summary

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)

Interventions

DRUGIntrapleurally Alteplase vs Intrapleurally Urokinase

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.	Evaluation at three and 6 days of treatment	It will be also an evaluation at one month, six months and one year

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026