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

Sponsor

University of Copenhagen (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04514978

Collaborator

World Anti-doping Agency (Other), University of California, Los Angeles (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Procedure: Blood donation and blood transfusion	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

ExplorativeExplorative

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

An algorithm was created using randomizer.org

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Aug 31, 2019

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Hemoglobin centration [6 days after reinfusion]
The effect of the intervention on [Hb] levels will be investigated
reticulocyte percentage [6 days after reinfusion]
The effect of the intervention on ret% levels will be investigated
OFF-score [6 days after reinfusion]
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
Homeostatic markers of iron metabolism [6 days after reinfusion]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition, Exercise and Sports	Copenhagen		Denmark	2100

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nikolai Nordsborg, Associate professor, Head of Department, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT04514978

Other Study ID Numbers:

H-17024876

First Posted:

Aug 17, 2020

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 24, 2022