Home Treatment of Pulmonary Embolism

NCT ID: NCT00214929

Last Updated: 2005-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-08-31

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).

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; Therapy; Home Nursing; Economics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

treatment at home

Intervention Type: BEHAVIORAL

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.
• Life expectancy < 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Society of Pneumology and Thoracic Surgery

OTHER

Sponsor Role: collaborator

Carlos III Health Institute

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Remedios Otero, MD

Role: STUDY_CHAIR

Pneumology Service of Virgen de Rocio Hospital (Spain)

Fernando Uresandi, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service.Cruces Hospital (Spain)

David Jimenez, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service. Ramon y Cajal Hospital (Spain)

Miguel A. Cabezudo, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service. H. Asturias (Spain)

Francisco Conget, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service. Clinic Hospital of Zaragoza (Spain)

Dolores Nauffal, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service. La Fe Hospital (Spain)

Mikel Oribe, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service. Galdakao Hospital (Spain)

Jose L. Lobo, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service. Txagorritxu Hospital (Spain)

Fulgencio Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service. 12 de Octubre Hospital (Spain)

Elena Laserna, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Service. S.Juan de Dios Hospital (Spain)

Locations

Pneumology Service of HVR

Seville, Seville, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 19853892 (View on PubMed)

Related Links

http://www.riete.org

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

Other Identifiers

PIO30192

Identifier Type: -

Identifier Source: org_study_id