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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04514978
• Other study ID #: H-17024876
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: January 31, 2024
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	University of California, Los Angeles, World Anti-doping Agency

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin centration	The effect of the intervention on [Hb] levels will be investigated	6 days after reinfusion
Primary	reticulocyte percentage	The effect of the intervention on ret% levels will be investigated	6 days after reinfusion
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.