Status:
UNKNOWN
Home Treatment of Pulmonary Embolism
Lead Sponsor:
Carlos III Health Institute
Collaborating Sponsors:
Spanish Society of Pneumology and Thoracic Surgery
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 be...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00214929
Start Date
December 1 2004
End Date
August 1 2005
Last Update
December 9 2005
Active Locations (1)
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1
Pneumology Service of HVR
Seville, Seville, Spain, 41013