CompletedNot Applicable

Respiratory Variations For Assessing Blood Withdrawal

France27 participantsStarted 2015-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT03066414

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Genetic Hemochromatosis trials