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

• ClinicalTrials.gov Identifier: NCT01246453
• Recruitment Status: Completed
• First Posted: November 23, 2010
• Last Update Posted: July 18, 2011
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Information provided by: Hospital Universitari Vall d'Hebron Research Institute

Tracking Information

• First Submitted Date: November 18, 2010
• First Posted Date: November 23, 2010
• Last Update Posted Date: July 18, 2011
• Study Start Date: December 2003
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 23, 2010)

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

Original Primary Outcome Measures (submitted: November 22, 2010)

To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema. [ Time Frame: Evaluation at three and 6 days of treatment ]

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

• Current Secondary Outcome Measures (submitted: November 22, 2010): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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)

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Empyema, Pleural
• Pleural Effusion
• Pleural Diseases

Intervention

Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

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

Study Arms

• Active Comparator: urokinase
  Intervention: Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase
• Active Comparator: Alteplase
  Intervention: Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 22, 2010): 204
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT01246453
• Other Study ID Numbers: EC07/90479
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospital Universitari Vall d'Hebron Research Institute
• Verification Date: July 2011