Empyema, PleuralPhase 4NCT01246453
Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema
A Phase 4 study testing Intrapleurally Alteplase vs Intrapleurally Urokinase in people with Empyema, Pleural and Pleural Effusion, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Empyema, Pleural, Pleural Effusion, Pleural Diseases
- What is being tested?
- Intrapleurally Alteplase vs Intrapleurally Urokinase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2003to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Empyema and Complex Complicated Parapneumonic Pleural Effusion
Who cannot join
- Pregnancy or breastfeeding
- Critically illness
- Systemic anticoagulant treatment
- Coagulation Disorder
- Bronchopleural fistula
- Active bleeding
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Vall d'Hebron
Barcelona, Catalonia, 5
Hospital Arnau de Vilanova
Lleida, Catalonia
About this study
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
- 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
- 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)
- Conditions
- Empyema, Pleural, Pleural Effusion, Pleural Diseases
- Being tested
- Intrapleurally Alteplase vs Intrapleurally Urokinase
- Medical subject headings
- Empyema, Pleural, Pleural Effusion, Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapleurally Alteplase vs Intrapleurally UrokinaseDrug
Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days
| Study group | Role | What they receive |
|---|---|---|
| urokinase | Active comparator | Not described Receives: Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase |
| Alteplase | Active comparator | Not described Receives: Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Evaluation at three and 6 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startDec 2003
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Empyema, PleuralStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246453
- Sponsor's protocol ID
- EC07/90479
- Status last verified
- Jul 2011
- First submitted
- 18 Nov 2010
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01246453
- Acronym / sponsor ID
- EC07/90479
- Conditions
- Empyema, Pleural, Pleural Effusion, Pleural Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urokinase | Active comparator | Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase |
| Alteplase | Active comparator | Drug: Intrapleurally Alteplase vs Intrapleurally Urokinase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Empyema and Complex Complicated Parapneumonic Pleural Effusion
Key exclusion criteria (12 listed)
- Pregnancy or breastfeeding
- Critically illness
- Systemic anticoagulant treatment
- Coagulation Disorder
- Bronchopleural fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrapleurally Alteplase vs Intrapleurally UrokinaseAlteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days | Drug | Alteplase, urokinase |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
- Derived from this study: PubMed 26423784Aleman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrapleurally Alteplase vs Intrapleurally Urokinase in people with Empyema, Pleural and Pleural Effusion, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.