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Respiratory Variations For Assessing Blood Withdrawal (ReVAs)

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ClinicalTrials.gov Identifier: NCT03066414
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment
Genetic Hemochromatosis Procedure: echography

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Respiratory Variations in Diameters of the Inferior Vena Cava and the Internal Jugular Vein to Assess Blood Withdrawal in Patients With Genetic Hemochromatosis
Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


Group/Cohort Intervention/treatment
non-obese patients with genetic hemochromatosis

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-obese patients with genetic hemochromatosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066414


Locations
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France
Hôpital Roger Salengro, CHRU de Lille
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Sébastien Preau, MD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03066414     History of Changes
Other Study ID Numbers: 2013_38
2013-A01689-36 ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
hemochromatosis
blood withdrawal
respiratory variations
inferior vena cava
internal jugular vein
ultrasound
ultrasonography
echography
Additional relevant MeSH terms:
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Hemochromatosis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases