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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

September 16, 2005
December 8, 2005
December 2004
Not Provided
  • -Thromboembolic recurrences
  • -Bleeding Complications
  • -Deaths
Same as current
Complete list of historical versions of study NCT00214929 on ClinicalTrials.gov Archive Site
-Quality of life
Same as current
Not Provided
Not Provided
 
Home Treatment of Pulmonary Embolism
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

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Embolism
Behavioral: treatment at home
Not Provided
Otero R, Uresandi F, Jiménez D, Cabezudo MA, Oribe M, Nauffal D, Conget F, Rodríguez C, Cayuela A. Home treatment in pulmonary embolism. Thromb Res. 2010 Jul;126(1):e1-5. Epub 2009 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
August 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00214929
PIO30192
Not Provided
Not Provided
Carlos III Health Institute
Spanish Society of Pneumology and Thoracic Surgery
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)
Carlos III Health Institute
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP