Viewing Study NCT00214929



Ignite Creation Date: 2024-05-05 @ 12:01 PM
Last Modification Date: 2024-10-26 @ 9:18 AM
Study NCT ID: NCT00214929
Status: UNKNOWN
Last Update Posted: 2005-12-09
First Post: 2005-09-16

Brief Title: Home Treatment of Pulmonary Embolism
Sponsor: Carlos III Health Institute
Organization: Carlos III Health Institute

Study Overview

Official Title: Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism
Status: UNKNOWN
Status Verified Date: 2005-08
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The best management in selected patients of pulmonary Embolism PE should be at home The efficacy and safety treatments 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None