NCT02518880

Brief Summary

To understand the cardiovascular reactions of the human body to changing conditions of gravity is an important aim of space science. In this context, cardiac output (CO) is a key value to estimate the human cardiovascular system. The main objective of this experiment is to determine the effects of parabolic flight on intravascular volume, and how these changes modulate the complex haemodynamics induced by the parabolas.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy-volunteers

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

Study Start

First participant enrolled

March 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

1.9 years

First QC Date

August 6, 2015

Last Update Submit

August 6, 2015

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • haemoglobin concentration

    baseline

Study Arms (1)

Plasma volume measurements

OTHER
Other: Parabolic flightOther: plasma volume measurements

Interventions

Parabolic flightOTHER
Plasma volume measurements
plasma volume measurementsOTHER
Plasma volume measurements

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers (men or women),
  • aged from 18 to 55,
  • affiliated to a Social Security system,
  • who accept to take part in the study,
  • who have given their written stated consent,
  • who already participated in parabolic flights (even in the same campaign)
  • All subjects will pass a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection

You may not qualify if:

  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

Location

Study Design

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

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 10, 2015

Study Start

March 1, 2010

Primary Completion

February 1, 2012

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations

FR(1)