NCT05287334

Brief Summary

The project focuses on the possibility of detecting blood loss using electrical impedance tomography. Based on previous animal experiments, it was found that the bolus of saline significantly affects the signal of chest bioimpedance. It is assumed that blood loss of a similar volume will cause a similar signal change with the opposite trend. The aim of this project is to determine whether there is a significant change in the thoracic electrical impedance tomography signal when blood loss is caused by voluntary blood donation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

March 10, 2022

Last Update Submit

August 8, 2022

Conditions

Blood Loss

Keywords

Blood donation, EIT

Outcome Measures

Primary Outcomes (1)

  • Change in chest electrical impedance due to blood loss.

    A change in the electrical impedance of the chest of a voluntary blood donor caused by a blood donation.

    Time frame of one voluntary blood donation process (15 min)

Study Arms (1)

Voluntary blood donors

EXPERIMENTAL

Voluntary blood donors undergoing standard blood donation while measuring electrical impedance of the chest .

Device: Electrical impedance tomography measurement

Interventions

Electrical impedance tomography measurementDEVICE

During standard blood donation, donors' chest bioimpedance will be measured using electrical impedance tomography.

Voluntary blood donors

Eligibility Criteria

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

You may qualify if:

  • voluntary blood donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Czech Technical University, Faculty of Biomedical Engineering

Kladno, 272 01, Czechia

RECRUITING

Czech technical university in Prague, Facutly of biomedical engineering

Kladno, 27201, Czechia

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vaclav Ort, M.Eng.

    Czech Technical University in Prague, Fac. of Biomedical Engineering

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vaclav Ort, M.Eng.

CONTACT

+420 731 577 649ortvacla@fbmi.cvut.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single group assignment. Approx 10-15 voluntary blood donors.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

July 1, 2022

Primary Completion

October 10, 2022

Study Completion

December 31, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CZ(2)