EUCTR2019-000266-37-ES
Active, not recruiting
Phase 1
Randomized clinical trial to evaluate the efficacy and safety of the treatment with supplementary oxygen in patients with Intermediate-Risk pulmonary embolism (PE) - AIRE
Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal0 sites100 target enrollmentJune 11, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute symptomatic pulmonary embolism
- Sponsor
- Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
- •2\) Disfuntion of right ventricle (quotient between RVDD and LVDD \> 1\.0 in the apical 4\-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
- •3\) Signed and dated informed consent of the subject.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 50
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •1\)\< 18 years old.
- •2\)Allergy to iodinated contrast.
- •3\)Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft\-Gault formula.
- •4\)Use of chronic oxygen therapy.
- •5\)Hypercapnia (pCO2 \>50 mmHg at the time of diagnosis).
- •6\)Basal echocardiography technically unsuitable.
- •7\)Contraindication to anticoagulant therapy.
- •8\)Symptoms duration \>10 days.
- •9\)Haemodynamic instability.
- •10\)Participation in other clinical trials for PE treatment during the present clinical trial.
Outcomes
Primary Outcomes
Not specified
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