Home Treatment of Pulmonary Embolism

December 8, 2005 updated by: Carlos III Health Institute

Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41013
        • Pneumology Service of HVR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
-Thromboembolic recurrences
-Bleeding Complications
-Deaths

Secondary Outcome Measures

Outcome Measure
-Quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos III Health Institute

Collaborators

Spanish Society of Pneumology and Thoracic Surgery

Investigators

  • 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 9, 2005

Last Update Submitted That Met QC Criteria

December 8, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIO30192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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