Home Treatment of Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00214929
• Other study ID #: PIO30192
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: December 8, 2005
• Start date: December 2004
• Est. completion date: August 2005

Study information

• Verified date: August 2005
• Source: Carlos III Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Behavioral:
• treatment at home

Locations

Country	Name	City	State
Spain	Pneumology Service of HVR	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Carlos III Health Institute	Spanish Society of Pneumology and Thoracic Surgery

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-Thromboembolic recurrences
Primary	-Bleeding Complications
Primary	-Deaths
Secondary	-Quality of life

External Links

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