Home Treatment of Pulmonary Embolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Carlos III Health Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Spanish Society of Pneumology and Thoracic Surgery
Information provided by:
Carlos III Health Institute
ClinicalTrials.gov Identifier:
NCT00214929
First received: September 16, 2005
Last updated: December 8, 2005
Last verified: August 2005
  Purpose

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


Condition Intervention Phase
Pulmonary Embolism
Behavioral: treatment at home
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Carlos III Health Institute:

Primary Outcome Measures:
  • -Thromboembolic recurrences
  • -Bleeding Complications
  • -Deaths

Secondary Outcome Measures:
  • -Quality of life

Study Start Date: December 2004
Estimated Study Completion Date: August 2005
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214929

Locations
Spain
Pneumology Service of HVR
Seville, Spain, 41013
Sponsors and Collaborators
Carlos III Health Institute
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)
  More Information

Additional Information:
No publications provided by Carlos III Health Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00214929     History of Changes
Other Study ID Numbers: PIO30192
Study First Received: September 16, 2005
Last Updated: December 8, 2005
Health Authority: Spain: Ministry of Health

Keywords provided by Carlos III Health Institute:
Pulmonary Embolism
Therapy
Home Nursing
Economics

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014