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Respiratory Variations For Assessing Blood Withdrawal

Respiratory Variations in Diameters of the Inferior Vena Cava and the Internal Jugular Vein to Assess Blood Withdrawal in Patients With Genetic Hemochromatosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03066414
Acronym
ReVAs
Enrollment
27
Registered
2017-02-28
Start date
2015-02-28
Completion date
2016-06-30
Last updated
2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Hemochromatosis

Keywords

hemochromatosis, blood withdrawal, respiratory variations, inferior vena cava, internal jugular vein, ultrasound, ultrasonography, echography

Brief summary

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.

Interventions

PROCEDUREechography

The inferior vena cava and the internal jugular vein diameters were measured by echography before and after blood withdrawal during a standardized respiratory maneuver

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients of \> or equal 18 years * genetic hemochromatosis * undergoing a therapeutic blood withdrawal * health insured * non-obese (body mass index \<30Kg/m²)

Exclusion criteria

* pregnancy * transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters * clinical signs of active exhalation

Design outcomes

Primary

MeasureTime frameDescription
blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST)during a standardized respiratory maneuver, an average 1 hour maximumThe 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.

Secondary

MeasureTime frameDescription
blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (ΔIJVST)during a standardized respiratory maneuver, an average 1 hour maximumThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026