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Capturing physiological responses to blood donation using a portable sensor

Predicting vasovagal and other adverse events in Australian voluntary blood donors using a portable sensor that measures bio-signal data (PREVENT)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17105027
Enrollment
560
Registered
2021-12-07
Start date
2021-11-23
Completion date
Unknown
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasovagal/pre faint symptoms in voluntary whole blood and apheresis plasma donors Signs and Symptoms

Interventions

Immediately after donor registration and providing consent, an ambulatory physiological monitor (e.g., the ‘evu TPS’ sensor
https://evutps.com/en/) will be attached to the participant’s finger to monitor autonomic activity throughout donation, from the point of consent up until arrival at the refreshment area after donatio

Sponsors

Australian Red Cross Lifeblood
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Eligible to donate as per the Australian Red Cross Lifeblood Guidelines for the Selection of Blood Donors 2. Donating whole blood or plasma for the first time 3. Willing and able to provide informed consent 4. Has a plasma or whole blood appointment at one of the participating donor centres (appointment made as a walk-in donor or scheduled appointment)

Exclusion criteria

Exclusion criteria: 1. Unwilling or unable to provide informed consent 2. Lack of understanding of the English language necessary to complete questionnaires. This study will not use translation services or interpreters 3. Contacted for a research study in the last 6 months as per Lifeblood contact policy 4. Donors with therapeutic, autologous, sample or platelet donation appointments 5. Lifeblood employees

Design outcomes

Primary

MeasureTime frame
1. Self-reported vasovagal symptoms measured using the Blood Donation Reactions Inventory (BDRI) at the haemoglobin test, needle insertion, first red cell return (plasma only), saline administration (plasma only), needle removal, and post-donation 2. Donation fear measured using a single fear question pre- and post-donation 3. Venipuncture pain measured using a self-report post-donation 4. Donor anxiety measured using the Blood Donor Anxiety Scale post-donation 5. Donor satisfaction with biometric sensor device measured using a self-report post-donation

Secondary

MeasureTime frame
1. Staff-recorded vasovagal reactions measured using Australian Red Cross Lifeblood standard procedures at any point at the donation centre 2. Donor return measured using Australian Red Cross Lifeblood records at 6-month follow-up 3. Time taken to return measured using the donor’s next attendance date as recorded by Australian Red Cross Lifeblood at 6-month follow up

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026