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Clinical Trials/EUCTR2019-000266-37-ES
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.

Registry
who.int
Start Date
June 11, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal

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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