Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
27 participants
OBSERVATIONAL
2015-02-28
2016-06-30
Brief Summary
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DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.
PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding.
INTERVENTIONS: Ultrasound measures and collected clinical parameters before and after a therapeutic bleeding, during a standardized respiratory maneuver.
MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. It measured the minimal and maximal IVC and IJV diameters during a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as follows: \[(maximal diameter - minimal diameter)/maximal diameter\].100.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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non-obese patients with genetic hemochromatosis
PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding.
INTERVENTIONS: The investigators performed ultrasound measurements (echography) and collected clinical parameters before and after a 300 to 500ml therapeutic bleeding, during a standardized respiratory maneuver.
echography
The inferior vena cava and the internal jugular vein diameters were measured by echography before and after blood withdrawal during a standardized respiratory maneuver
Interventions
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echography
The inferior vena cava and the internal jugular vein diameters were measured by echography before and after blood withdrawal during a standardized respiratory maneuver
Eligibility Criteria
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Inclusion Criteria
* genetic hemochromatosis
* undergoing a therapeutic blood withdrawal
* health insured
* non-obese (body mass index \<30Kg/m²)
Exclusion Criteria
* transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters
* clinical signs of active exhalation
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Sébastien Preau, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hôpital Roger Salengro, CHRU de Lille
Lille, , France
Countries
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Other Identifiers
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2013-A01689-36
Identifier Type: OTHER
Identifier Source: secondary_id
2013_38
Identifier Type: -
Identifier Source: org_study_id