Pulmonary EmbolismPhase 4NCT00214929
Home Treatment of Pulmonary Embolism
A Phase 4 study testing treatment at home in people with Pulmonary Embolism, run by Carlos III Health Institute at 1 site in Spain.
Trial summary
The best management in selected patients of pulmonary Embolism (PE) should be at home. The efficacy and safety treatment´s at home versus at hospital should be similar and quality of life should be better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- treatment at home
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Dec 2004to Aug 2005
- 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
- The consecutive outpatients subjects diagnosed of PE at 10 different Spanish hospitals.
- A score of 2 or under in our prediction rule (risk score for short-term)
- Signed written Informed consent
Who cannot join
- A score over 2 in our prediction rule
- Patients with a PE requiring thrombolysis or surgical thrombectomy
- Patients with right ventricular dyskinesia in echocardiography at 48 hours from heparin therapy. (It is not necessary echocardiography for the model of discharge at 5 days)
- Troponin level over 0,1 g/L
- Patiens requiring oxygen therapy or under 93% in oxygen saturation level.
- Patients requiring intravenous analgesic therapy
Show all 17Show fewer
- Patients with some medical or surgical conditions requiring to stay at hospital
- Patients with advanced chronic cardiovascular diseases (dyspnea III-IV NYHA)
- Patients with advanced chronic respiratory diseases (several COPD criteria of GOLD with FEV1< 50%)
- Documented congenital or acquired bleeding tendency /disorder (s)
- Documented current ulceration or angiodysplastic gastrointestinal disease
- Hemorrhagic stroke or recent (< 3 months prior to randomization) brain, spinal, or ophthalmological surgery.
- Recent surgery < 3 days
- Pregnancy
- Several Obesity (CMI over 30)
- Patients could not complete the treatment at home.
- Life expectancy < 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism
The best management in selected patients of pulmonary Embolism (PE) should be at home. The efficacy and safety treatment´s at home versus at hospital should be similar and quality of life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH) at home for PE is at least as effective and safe at home as at hospital
Read the detailed description
In order to carry out the Cooperative Investigation Plan for home treatment of pulmonary embolism, a network of multidisciplinary groups was built with the participation of 10 groups, distributed in 6 different regions and integrated within the Spanish Society of Pneumology and Thoracic Surgery (SEPAR).
Those groups will share a database integrated in the Spanish Registry on Thromboembolic Disease (RIETE), which is a project already being carried out and in which many of the groups of the network already participate.
The research project will be a study developed in two phases. In the first phase, predictive profiles for a favourable progression of the disease in patients with pulmonary embolism will be studied using the actual management of the disease with the current assistance model.
In the second phase, a randomized study comparing the efficacy and safety of two models of home treatment ( discharge from hospital during the first 72 hours after the diagnosis of PE and discharge from hospital during the first 5 days) in patients previously selected, according to predefined criteria which were modified on the basis of the results of phase I versus the current assistance model will be developed
The results will be measured in terms of efficacy, safety, economic burden, and quality of life in both models (at home and at hospital).
- Conditions
- Pulmonary Embolism
- Being tested
- treatment at home
- Keywords
- Pulmonary Embolism, Therapy, Home Nursing, Economics
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment at homeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
-Thromboembolic recurrences
-Bleeding Complications
-Deaths
Secondary outcomes (1)
-Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2004
- Study completionAug 2005
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 Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- None (open label)
Sponsor and investigators
- Lead sponsor
- Carlos III Health Institute
- Sponsor type
- Other government
- Collaborators
- Spanish Society of Pneumology and Thoracic Surgery
- Investigators
- Remedios Otero, MD, Study chair, Pneumology Service of Virgen de Rocio Hospital (Spain)Fernando Uresandi, MD, Principal investigator, Pneumology Service.Cruces Hospital (Spain)David Jimenez, MD, Principal investigator, Pneumology Service. Ramon y Cajal Hospital (Spain)Miguel A. Cabezudo, MD, Principal investigator, Pneumology Service. H. Asturias (Spain)Francisco Conget, MD, Principal investigator, Pneumology Service. Clinic Hospital of Zaragoza (Spain)Dolores Nauffal, MD, Principal investigator, Pneumology Service. La Fe Hospital (Spain)Mikel Oribe, MD, Principal investigator, Pneumology Service. Galdakao Hospital (Spain)Jose L. Lobo, MD, Principal investigator, Pneumology Service. Txagorritxu Hospital (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214929
- Sponsor's protocol ID
- PIO30192
- Status last verified
- Aug 2005
- First submitted
- 16 Sep 2005
- Last updated
- 9 Dec 2005
- Results posted
- No
Publications
Otero R, Uresandi F, Jimenez D, Cabezudo MA, Oribe M, Nauffal D, Conget F, Rodriguez C, Cayuela A. Home treatment in pulmonary embolism. Thromb Res. 2010 Jul;126(1):e1-5. doi: 10.1016/j.thromres.2009.09.026. Epub 2009 Oct 24.
PubMed 19853892
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT00214929
- Acronym / sponsor ID
- PIO30192
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Therapy, Home Nursing, Economics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Carlos III Health InstituteOther government
- Collaborators
- Spanish Society of Pneumology and Thoracic Surgery
- Study start
- Dec 2004
- Study completion
- Aug 2005
- First posted
- 22 Sep 2005 (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.
The best management in selected patients of pulmonary Embolism (PE) should be at home. The efficacy and safety treatment´s at home versus at hospital should be similar and quality of life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH) at home for PE is at least as effective and safe at home as at hospital
Detailed description
In order to carry out the Cooperative Investigation Plan for home treatment of pulmonary embolism, a network of multidisciplinary groups was built with the participation of 10 groups, distributed in 6 different regions and integrated within the Spanish Society of Pneumology and Thoracic Surgery (SEPAR).
Those groups will share a database integrated in the Spanish Registry on Thromboembolic Disease (RIETE), which is a project already being carried out and in which many of the groups of the network already participate.
The research project will be a study developed in two phases. In the first phase, predictive profiles for a favourable progression of the disease in patients with pulmonary embolism will be studied using the actual management of the disease with the current assistance model.
In the second phase, a randomized study comparing the efficacy and safety of two models of home treatment ( discharge from hospital during the first 72 hours after the diagnosis of PE and discharge from hospital during the first 5 days) in patients previously selected, according to predefined criteria which were modified on the basis of the results of phase I versus the current assistance model will be developed
The results will be measured in terms of efficacy, safety, economic burden, and quality of life in both models (at home and at hospital).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The consecutive outpatients subjects diagnosed of PE at 10 different Spanish hospitals.
- A score of 2 or under in our prediction rule (risk score for short-term)
- Signed written Informed consent
Key exclusion criteria (17 listed)
- A score over 2 in our prediction rule
- Patients with a PE requiring thrombolysis or surgical thrombectomy
- Patients with right ventricular dyskinesia in echocardiography at 48 hours from heparin therapy. (It is not necessary echocardiography for the model of discharge at 5 days)
- Troponin level over 0,1 g/L
- Patiens requiring oxygen therapy or under 93% in oxygen saturation level.
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 |
|---|---|---|
| treatment at home | Behavioural | – |
Primary outcome
-Thromboembolic recurrences
-Bleeding Complications
-Deaths
1 secondary outcome
-Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2005.
- Derived from this study: PubMed 19853892Otero R, Uresandi F, Jimenez D, Cabezudo MA, Oribe M, Nauffal D, Conget F, Rodriguez C, Cayuela A. Home treatment in pulmonary embolism. Thromb Res. 2010 Jul;126(1):e1-5. doi: 10.1016/j.thromres.2009.09.026. Epub 2009 Oct 24.
- The clinical variables have been collected from the Spanish Computerized Registry of Patients with Venous Thromboembolism (R.I.E.T.E.) (www.riete.org)Link provided by the sponsor.
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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.
Remedios Otero, MD study chair
Pneumology Service of Virgen de Rocio Hospital (Spain)
Fernando Uresandi, MD principal investigator
Pneumology Service.Cruces Hospital (Spain)
David Jimenez, MD principal investigator
Pneumology Service. Ramon y Cajal Hospital (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing treatment at home in people with Pulmonary Embolism, run by Carlos III Health Institute at 1 site 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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 9 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
-Thromboembolic recurrences. The study lists 3 primary outcomes in all. 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 NCT00214929, 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 9 Dec 2005.