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Respiratory Variations For Assessing Blood Withdrawal (ReVAs)

U

University Hospital, Lille

Status

Completed

Conditions

Genetic Hemochromatosis

Treatments

Procedure: echography

Study type

Observational

Funder types

Other

Identifiers

NCT03066414
2013-A01689-36 (Other Identifier)
2013_38

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

27 participants in 1 patient group

non-obese patients with genetic hemochromatosis
Description:
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.
Treatment:
Procedure: echography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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