Home Treatment of Pulmonary Embolism
Recruitment status was Active, not recruiting
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
|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|
- -Thromboembolic recurrences
- -Bleeding Complications
- -Quality of life
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||August 2005|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214929
|Pneumology Service of HVR|
|Seville, Spain, 41013|
|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)|