An observational study in Genetic Hemochromatosis, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by University Hospital, Lille · Observational
OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC) and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST) increase after a therapeutic bleeding in spontaneously breathing and non-obese patients with genetic hemochromatosis.
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.
67 studies on the registry are indexed under Hemochromatosis; 4 are open to participants now.
This study's enrollment of 27 is below the median of 100 across 18 observational studies indexed under Hemochromatosis.
Browse Hemochromatosis studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
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Non-obese patients with genetic hemochromatosis
Exclusion Criteria:
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.
Procedure: 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
blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST)
The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IVC diameters during a standardized ventilation. ΔIVCST was calculated as follows: \[(maximal diameter - minimal diameter)/maximal diameter\].100.
Time frame: during a standardized respiratory maneuver, an average 1 hour maximum
blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (ΔIJVST)
The primary endpoint was the ΔIJVST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IJV diameters during a standardized ventilation. ΔIJVST was calculated as follows: \[(maximal diameter - minimal diameter)/maximal diameter\].100.
Time frame: during a standardized respiratory maneuver, an average 1 hour maximum
Plan to share: No
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University Hospital, Lille