CClinicalTrials.gg
CompletedNCT01246453Updated Jul 18, 2011

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

A Phase 4 interventional study of Intrapleurally Alteplase vs Intrapleurally Urokinase in Empyema, Pleural, Pleural Effusion and Pleural Diseases, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-18.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)
02

Conditions studied

  • Empyema, Pleural
  • Pleural Effusion
  • Pleural Diseases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Empyema and Complex Complicated Parapneumonic Pleural Effusion

Exclusion criteria

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
204 participants (estimated)

Study arms

  • Active comparator
    urokinase

    Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

  • Active comparator
    Alteplase

    Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase

Interventions

  • DrugIntrapleurally Alteplase vs Intrapleurally Urokinase

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

05

What researchers measure

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

    Time frame: 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

    Time frame: Evaluation at three and 6 days of treatment

06

Study locations

2 sites
  • Hospital Vall d'Hebron
    Barcelona, Catalunya 5, Spain
  • Hospital Arnau de Vilanova
    LLeida, Catalunya, Spain
07

References and documents

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. PubMed 26423784 ↗
08

Registry details

Key details

Study ID
NCT01246453
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
First posted
Nov 23, 2010
Start date
Dec 2003
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jul 18, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion