Clinical trial NCT00214929: Home Treatment of Pulmonary Embolism
Official title: Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Therapy
Home Nursing
Economics
Lead sponsor: Carlos III Health Institute
Sponsor class: OTHER_GOV
Collaborators: name: Spanish Society of Pneumology and Thoracic Surgery
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.
* Exclusion criteria related to study procedures
* Life expectancy \< 3 months

Primary outcomes:
measure: -Thromboembolic recurrences
measure: -Bleeding Complications
measure: -Deaths
Secondary outcomes:
measure: -Quality of life
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Pneumology Service of HVR
Study officials:
affiliation: Pneumology Service of Virgen de Rocio Hospital (Spain)
name: Remedios Otero, MD
role: STUDY_CHAIR
affiliation: Pneumology Service.Cruces Hospital (Spain)
name: Fernando Uresandi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology Service. Ramon y Cajal Hospital (Spain)
name: David Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology Service. H. Asturias (Spain)
name: Miguel A. Cabezudo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology Service. Clinic Hospital of Zaragoza (Spain)
name: Francisco Conget, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology Service. La Fe Hospital (Spain)
name: Dolores Nauffal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology Service. Galdakao Hospital (Spain)
name: Mikel Oribe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology Service. Txagorritxu Hospital (Spain)
name: Jose L. Lobo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology Service. 12 de Octubre Hospital (Spain)
name: Fulgencio Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology Service. S.Juan de Dios Hospital (Spain)
name: Elena Laserna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.