Home Treatment of Pulmonary Embolism

NCT00214929 | Unknown Phase 4

• 1 other identifier: PIO30192
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; Therapy; Home Nursing; Economics

Outcome Measures

Primary Outcomes (3)

• -Thromboembolic recurrences

• -Bleeding Complications

• -Deaths

Secondary Outcomes (1)

• -Quality of life

Interventions

treatment at home BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Carlos III Health Institute: lead
• Spanish Society of Pneumology and Thoracic Surgery: collaborator

Study Sites (1)

Pneumology Service of HVR

Seville, Seville, 41013, Spain

Location

Related Publications (1)

• Otero R, Uresandi F, Jimenez D, Cabezudo MA, Oribe M, Nauffal D, Conget F, Rodriguez C, Cayuela A. Home treatment in pulmonary embolism. Thromb Res. 2010 Jul;126(1):e1-5. doi: 10.1016/j.thromres.2009.09.026. Epub 2009 Oct 24.

  PMID: 19853892 DERIVED

Related 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)

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Remedios Otero, MD

  Pneumology Service of Virgen de Rocio Hospital (Spain)

  STUDY CHAIR

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2004
• Study Completion: August 1, 2005
• Last Updated: December 9, 2005

Record last verified: 2005-08

Locations

ES (1)