The Effect of Blood Donation on Hematological and Iron Indices and Detection of Autologous Blood Transfusion

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Procedure: Blood donation and blood transfusion

Detailed Description

Blood donations is a essential and crucial in the clinic. A whole blood donation results in the loss of 450-525 mL whole blood in eight to ten minutes and is known to reduce body iron stores with 200-265 mg iron depending on the donor's age, hematocrit and sex and accounts for 25% of average tissue iron stores in men and up to 75% in women.In the present study, the investigators aimed at thoroughly evaluate 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 red blood cell measures up to 4 weeks after donation in healthy, non-anemic, young men and women

Likewise, doping in sport is a major problem concerning both the health of the athletes and the integrity of sports. Despite major improvements in anti-doping work in recent years, it is still impossible to test for all existing and future doping strategies, such as manipulation with blood oxygen carrying capacity. A well-known doping strategy is autologous blood transfusion (ABT), and at present, the detection of ABT is a challenge for anti-doping authorities. The hypotheses for this study are that 1) ret% and abnormal blood profile score (ABPS) have higher sensitivity to micro-dose ABT compared to current variables in the Athlete Biological Passport (ABP); 2) The plasma concentration of hepcidin and erythroferrone (ERFE) is sensitive to micro-dose ABT; 3) Gender-specific variations in hematologic variables affect the interpretation of the athlete's biological passport.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Nutrition, Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood donation and transfusion; 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; 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.
No Intervention: Control group; Blood samples collected with same frequency as described in the intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endurance exercise performance measured as a preloaded 400 kcal time-trial	Endurance exercise performance are measured in a subgroup of 13 subjects.	6 days after reinfusion.
Maximal oxugen uptake (VO2max)	Maximal aerobic capacity is measured via a maximal oxygen uptake incremental test in a subgroup of 13 subjects.	6 days after reinfusion.
Mean corpuscular concentration	Markers of red blood cell size and hemoglobin content are collected and analyzed for Determining the impact of donation and reinfusion of blood.	6 days after reinfusion.
Mean corpuscular hemoglobin concentration	Markers of red blood cell size and hemoglobin content are collected and analyzed for Determining the impact of donation and reinfusion of blood.	6 days after reinfusion.
Mean corpuscular volume	Markers of red blood cell size and hemoglobin content are collected and analyzed for Determining the impact of donation and reinfusion of blood.	6 days after reinfusion.
Dried Blood Spots	Dried blood spots will be analyzed for the CD71/Band3 concentration as well as transcriptomic markers for reticolucytes including the ALAS2 L and LC.	6 days after reinfusion.

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: University of California, Los Angeles; World Anti-Doping Agency

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: H-17024876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Fully anonymous data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No