Clinical trial NCT04514978: The Effect of Blood Donation on Hematological and Iron Indices and Detection of Autologous Blood Transfusion
Official title: The Effect of Blood Donation on Hematological and Iron Indices and Detection of Autologous Blood Transfusion
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: World Anti-Doping Agency
name: University of California, Los Angeles
First posted: 2020-08-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Explorative
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin centration
timeFrame: 6 days after reinfusion
measure: reticulocyte percentage
timeFrame: 6 days after reinfusion
measure: OFF-score
timeFrame: 6 days after reinfusion
measure: Homeostatic markers of iron metabolism
timeFrame: 6 days after reinfusion
Secondary outcomes:
measure: Endurance exercise performance measured as a preloaded 400 kcal time-trial
timeFrame: 6 days after reinfusion.
measure: Maximal oxugen uptake (VO2max)
timeFrame: 6 days after reinfusion.
measure: Mean corpuscular concentration
timeFrame: 6 days after reinfusion.
measure: Mean corpuscular hemoglobin concentration
timeFrame: 6 days after reinfusion.
measure: Mean corpuscular volume
timeFrame: 6 days after reinfusion.
measure: Dried Blood Spots
timeFrame: 6 days after reinfusion.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
Study officials:
References:
citation: 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.