Respiratory Variations For Assessing Blood Withdrawal

Genetic Hemochromatosis Clinical Trial

— ReVAs  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066414
• Other study ID #: 2013_38
• Secondary ID: 2013-A01689-36
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: February 27, 2017
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: February 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genetic Hemochromatosis
• Hemochromatosis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (?IVCST)	The primary endpoint was the ?IVCST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IVC diameters during a standardized ventilation. ?IVCST was calculated as follows: [(maximal diameter - minimal diameter)/maximal diameter].100.	during a standardized respiratory maneuver, an average 1 hour maximum
Secondary	blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (?IJVST)	The primary endpoint was the ?IJVST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IJV diameters during a standardized ventilation. ?IJVST was calculated as follows: [(maximal diameter - minimal diameter)/maximal diameter].100.	during a standardized respiratory maneuver, an average 1 hour maximum