Respiratory Variations For Assessing Blood Withdrawal

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.

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Key information

Conditions

Genetic Hemochromatosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hemochromatosis Iron Metabolism Disorders Iron Overload Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

echography

Procedure

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

Primary outcomes

blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST)

Time frame: during a standardized respiratory maneuver, an average 1 hour maximum

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.

Secondary outcomes

blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (ΔIJVST)

Time frame: during a standardized respiratory maneuver, an average 1 hour maximum

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ReVAs

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 28, 2017
Registry last updated: Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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