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

NCT01246453 — Phase 4, Completed, 204 participants, Hospital Universitari Vall d'Hebron Research Institute

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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

Registry	NCT01246453
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	204 (Estimated)
Sponsor	Hospital Universitari Vall d'Hebron Research Institute (Other)
Conditions	Empyema, Pleural, Pleural Effusion, Pleural Diseases
Interventions	Intrapleurally Alteplase vs Intrapleurally Urokinase (Drug)
Dates	start 2003-12-01, primary completion 2010-12-01, completion 2010-12-01, first posted 2010-11-23, last updated 2011-07-18
Locations	2 sites in Spain

-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)

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+Arms and interventions

Arm	Type	Interventions	Description
urokinase	Active comparator	Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase
Alteplase	Active comparator	Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

Intrapleurally Alteplase vs Intrapleurally Urokinase (Drug): Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days

+Outcome measures

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. [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 [Evaluation at three and 6 days of treatment]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
Hospital Vall d'Hebron	Barcelona, Catalonia	Spain
Hospital Arnau de Vilanova	Lleida, Catalonia	Spain

+Publications

Results publication: 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. PMID 26423784

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