Home Treatment of Pulmonary Embolism - Full Text View

Sponsor:	Carlos III Health Institute
Collaborator:	Spanish Society of Pneumology and Thoracic Surgery
Information provided by:	Carlos III Health Institute
ClinicalTrials.gov Identifier:	NCT00214929

Purpose

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

Condition	Intervention	Phase
Pulmonary Embolism	Behavioral: treatment at home	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Embolism

U.S. FDA Resources

Further study details as provided by Carlos III Health Institute:

Primary Outcome Measures:

-Thromboembolic recurrences
-Bleeding Complications
-Deaths

Secondary Outcome Measures:

-Quality of life

Study Start Date:	December 2004
Estimated Study Completion Date:	August 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214929

Locations

Spain
Pneumology Service of HVR
Seville, Spain, 41013

Sponsors and Collaborators

Carlos III Health Institute

Spanish Society of Pneumology and Thoracic Surgery

Investigators

Study Chair:	Remedios Otero, MD	Pneumology Service of Virgen de Rocio Hospital (Spain)
Principal Investigator:	Fernando Uresandi, MD	Pneumology Service.Cruces Hospital (Spain)
Principal Investigator:	David Jimenez, MD	Pneumology Service. Ramon y Cajal Hospital (Spain)
Principal Investigator:	Miguel A. Cabezudo, MD	Pneumology Service. H. Asturias (Spain)
Principal Investigator:	Francisco Conget, MD	Pneumology Service. Clinic Hospital of Zaragoza (Spain)
Principal Investigator:	Dolores Nauffal, MD	Pneumology Service. La Fe Hospital (Spain)
Principal Investigator:	Mikel Oribe, MD	Pneumology Service. Galdakao Hospital (Spain)
Principal Investigator:	Jose L. Lobo, MD	Pneumology Service. Txagorritxu Hospital (Spain)
Principal Investigator:	Fulgencio Gonzalez, MD	Pneumology Service. 12 de Octubre Hospital (Spain)
Principal Investigator:	Elena Laserna, MD	Pneumology Service. S.Juan de Dios Hospital (Spain)

More Information

Additional Information:

The clinical variables have been collected from the Spanish Computerized Registry of Patients with Venous Thromboembolism (R.I.E.T.E.) (www.riete.org) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided by Carlos III Health Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Otero R, Uresandi F, Jiménez D, Cabezudo MA, Oribe M, Nauffal D, Conget F, Rodríguez C, Cayuela A. Home treatment in pulmonary embolism. Thromb Res. 2010 Jul;126(1):e1-5. Epub 2009 Oct 24.

ClinicalTrials.gov Identifier:	NCT00214929 History of Changes
Other Study ID Numbers:	PIO30192
Study First Received:	September 16, 2005
Last Updated:	December 8, 2005
Health Authority:	Spain: Ministry of Health

Keywords provided by Carlos III Health Institute:

Pulmonary Embolism
Therapy
Home Nursing
Economics

Additional relevant MeSH terms:

Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases

Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012