NCT01246453

Brief Summary

  • 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
  • Design: Multicentric, randomized, parallel, controlled and double blind
  • Main variable: Percentage of curation
  • Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
  • Duration of the treatment: Three days (main variable), and optional three days (secondary variable)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2011

Enrollment Period

7 years

First QC Date

November 18, 2010

Last Update Submit

July 15, 2011

Conditions

Empyema, PleuralPleural EffusionPleural Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

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

    Evaluation at three and 6 days of treatment

Secondary Outcomes (1)

  • 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

Study Arms (2)

urokinase

ACTIVE COMPARATOR
Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

Alteplase

ACTIVE COMPARATOR
Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

Interventions

Intrapleurally Alteplase vs Intrapleurally UrokinaseDRUG

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

Alteplaseurokinase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Empyema and Complex Complicated Parapneumonic Pleural Effusion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Vall d'Hebron

Barcelona, Catalonia, 5, Spain

Location

Hospital Arnau de Vilanova

Lleida, Catalonia, Spain

Location

Related Publications (1)

  • 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: 26423784DERIVED

MeSH Terms

Conditions

Empyema, PleuralPleural EffusionPleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsEmpyemaSuppurationRespiratory Tract DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 23, 2010

Study Start

December 1, 2003

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 18, 2011

Record last verified: 2011-07

Locations

ES(2)