Home Treatment of Pulmonary Embolism

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

treatment at home

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, Therapy, Home Nursing, Economics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pneumology Service of HVR

Outcomes

Primary Outcome Measures

-Thromboembolic recurrences

-Bleeding Complications

-Deaths

Secondary Outcome Measures

-Quality of life

Full Information

NCT ID

NCT00214929

First Posted

September 16, 2005

Last Updated

December 8, 2005

Sponsor

Carlos III Health Institute

Collaborators

Spanish Society of Pneumology and Thoracic Surgery

1. Study Identification

Unique Protocol Identification Number

NCT00214929

Brief Title

Home Treatment of Pulmonary Embolism

Official Title

Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Unknown status

Study Start Date

December 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Carlos III Health Institute

Collaborators

Spanish Society of Pneumology and Thoracic Surgery

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism

Keywords

Pulmonary Embolism, Therapy, Home Nursing, Economics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

treatment at home

Primary Outcome Measure Information:

Title

-Thromboembolic recurrences

Title

-Bleeding Complications

Title

-Deaths

Secondary Outcome Measure Information:

Title

-Quality of life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials: