NCT04514978

Brief Summary

Blood donations is a essential and crucial in the clinic. Normal biological variation of relevant biomarkers and hormones before the donation of 450 mL whole blood as well as the expected alterations in systemic levels of plasma iron indices and RBC measures up to 4 weeks after donation in healthy, non-anemic, young men and women is investigated Likewise, the possibilities for detecting autologous blood transfusion is investigated.

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
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

August 10, 2020

Last Update Submit

November 28, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Hemoglobin centration

    The effect of the intervention on \[Hb\] levels will be investigated

    6 days after reinfusion

  • reticulocyte percentage

    The effect of the intervention on ret% levels will be investigated

    6 days after reinfusion

  • OFF-score

    The effect of the intervention on OFF-score (an algorithm computed from reticulocyte percentage and hemoglobin concentration resulting in a arbitrary value) will be investigated

    6 days after reinfusion

  • Homeostatic markers of iron metabolism

    Markers of iron metabolism such as hepcidin and erythroferrone are collected and analyzed for evaluation of iron metabolism during and after donation and reinfusion of blood.

    6 days after reinfusion

Secondary Outcomes (6)

  • Endurance exercise performance measured as a preloaded 400 kcal time-trial

    6 days after reinfusion.

  • Maximal oxugen uptake (VO2max)

    6 days after reinfusion.

  • Mean corpuscular concentration

    6 days after reinfusion.

  • Mean corpuscular hemoglobin concentration

    6 days after reinfusion.

  • Mean corpuscular volume

    6 days after reinfusion.

  • +1 more secondary outcomes

Study Arms (2)

Blood donation and transfusion

EXPERIMENTAL

Donation and reinfusion of 1 unit whole blood and 130 mL packed red blood cells, respectively. Blood samples were collected at 8 weeks prior to donation for 12 subjects and 2 weeks prior to donation by 12 subjects. Blood samples were collected 3, 7, 14, 21, and 28 days after donation and 3, 6, 24 hours and 2, 3 and 6 days after reinfusion of blood.

Procedure: Blood donation and blood transfusion

Control group

NO INTERVENTION

Blood samples collected with same frequency as described in the intervention arm.

Interventions

Blood donation and blood transfusionPROCEDURE

24 subjects (12 female, 12 male) is phlebotomized and four weeks later \~130 mL packed red blood cells are re-infused in the same subjects.

Blood donation and transfusion

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Relative maximum oxygen uptake (VO2-max) of at least 55 ml O2/min/kg for male participants and 50 ml O2/min/kg for female participants

You may not qualify if:

  • Age
  • Insufficient fitness level
  • Blood donation 3 months prior to enrollment
  • Altitude exposure 2 months before enrollment
  • Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Breenfeldt Andersen A, Bejder J, Bonne TC, Sorensen H, Sorensen H, Jung G, Ganz T, Nemeth E, Secher NH, Johansson PI, Nordsborg NB. Hepcidin and Erythroferrone Complement the Athlete Biological Passport in the Detection of Autologous Blood Transfusion. Med Sci Sports Exerc. 2022 Sep 1;54(9):1604-1616. doi: 10.1249/MSS.0000000000002950. Epub 2022 Apr 25.

    PMID: 35482790DERIVED

MeSH Terms

Interventions

Blood DonationBlood Transfusion

Intervention Hierarchy (Ancestors)

Tissue and Organ ProcurementHealth ServicesHealth Care Facilities Workforce and ServicesBiological TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
An algorithm was created using randomizer.org
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Explorative
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Head of Department

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 17, 2020

Study Start

October 1, 2018

Primary Completion

August 31, 2019

Study Completion

January 31, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DK(1)