NCT03484052

Brief Summary

Interventional study with minimal risks and constraints, prospective, monocentric.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2018

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

March 16, 2018

Last Update Submit

May 22, 2023

Conditions

Transfusion

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the volemia

    Variation in height of the area where the right jugular vein collapses in centimeters from the angle of Louis.

    Baseline

Secondary Outcomes (4)

  • Transfusion tolerance

    Day 3

  • Interobserver variability

    Baseline

  • Interobserver variability

    Baseline

  • Semi-quantitative measurement variation in the height of the zone where the right jugular vein colludes

    Baseline

Study Arms (1)

Jugular ultrasound

OTHER
Other: Jugular ultrasound

Interventions

Jugular ultrasoundOTHER

Performing a jugular ultrasound by 2 operators before and after transfusion

Jugular ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major patient;
  • Requiring a transfusion of 2 or more red blood cells in a routine care situation (transfusion programmed in the context of a day hospital or a traditional hospitalization, except in cases of massive bleeding);
  • Affiliate or beneficiary of a social protection scheme;
  • Having given his written consent.

You may not qualify if:

  • Patient with clinical or biological criteria for admission to intensive care as defined in the 1999 US ICU Practice Guidelines;
  • Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, Britain, 35033, France

Location

Related Publications (1)

  • Henriot B, Scanff A, Sebillot M, Lautredoux F, Jego P. Jugular vein ultrasound for estimating changes in blood volume: a new tool for all physicians. Intern Emerg Med. 2021 Oct;16(7):2005-2007. doi: 10.1007/s11739-021-02792-y. Epub 2021 Jul 1. No abstract available.

    PMID: 34196887RESULT

Study Officials

  • JEGO Patrick

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 30, 2018

Study Start

May 15, 2018

Primary Completion

August 23, 2018

Study Completion

August 23, 2018

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

FR(1)