HealthyNCT04514978
The Effect of Blood Donation on Hematological and Iron Indices and Detection of Autologous Blood Transfusion
A study testing Blood donation and blood transfusion in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood donation and blood transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Age
- Insufficient fitness level
- Blood donation 3 months prior to enrollment
- Altitude exposure 2 months before enrollment
- Hypertension
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Blood donation and blood transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood donation and blood transfusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood donation and blood transfusion |
| Control group | No intervention | Blood samples collected with same frequency as described in the intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin centration
The effect of the intervention on [Hb] levels will be investigated
Measured: 6 days after reinfusion
reticulocyte percentage
The effect of the intervention on ret% levels will be investigated
Measured: 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
Measured: 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.
Measured: 6 days after reinfusion
Secondary outcomes (6)
Endurance exercise performance measured as a preloaded 400 kcal time-trial
Endurance exercise performance are measured in a subgroup of 13 subjects.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 days after reinfusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Oct 2018
- Primary completion31 Aug 2019
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Explorative
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- World Anti-Doping Agency, University of California, Los Angeles
- Responsible party
- Principal investigator, Nikolai Nordsborg, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514978
- Sponsor's protocol ID
- H-17024876
- Status last verified
- Nov 2023
- First submitted
- 10 Aug 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Fully anonymous data will be shared with other researchers.
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.
PubMed 35482790
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Donation on Hematological and Iron Indices and Detection of Autologous Blood Transfusion
- ClinicalTrials.gov ID
- NCT04514978
- Acronym / sponsor ID
- H-17024876
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- World Anti-Doping Agency, University of California, Los Angeles
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Explorative
| Arm | Type | Receives |
|---|---|---|
| Blood donation and transfusion | Experimental | Procedure: Blood donation and blood transfusionDonation 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. |
| Control group | No intervention | –Blood samples collected with same frequency as described in the intervention arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Age
- Insufficient fitness level
- Blood donation 3 months prior to enrollment
- Altitude exposure 2 months before enrollment
- Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood donation and blood transfusion24 subjects (12 female, 12 male) is phlebotomized and four weeks later ~130 mL packed red blood cells are re-infused in the same subjects. | Procedure or surgery | Blood donation and transfusion |
Primary outcome
Hemoglobin centration
Time frame: 6 days after reinfusion
The effect of the intervention on [Hb] levels will be investigated
reticulocyte percentage
Time frame: 6 days after reinfusion
The effect of the intervention on ret% levels will be investigated
OFF-score
Time frame: 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
Time frame: 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.
6 secondary outcomes
Endurance exercise performance measured as a preloaded 400 kcal time-trial
Time frame: 6 days after reinfusion.
Maximal oxugen uptake (VO2max)
Time frame: 6 days after reinfusion.
Mean corpuscular concentration
Time frame: 6 days after reinfusion.
Mean corpuscular hemoglobin concentration
Time frame: 6 days after reinfusion.
Mean corpuscular volume
Time frame: 6 days after reinfusion.
Dried Blood Spots
Time frame: 6 days after reinfusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 35482790Breenfeldt 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.
- Individual participant dataSharing planned: Undecided. Fully anonymous data will be shared with other researchers.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood donation and blood transfusion in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin centration (time frame: 6 days after reinfusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04514978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.