Hereditary HemochromatosisNCT05742035
Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.
A study testing Venipuncture in people with Hereditary Hemochromatosis and Hyperferritinemia, run by Interregionale Blutspende SRK at 2 sites in Switzerland.
Trial summary
Iron overload in hereditary hemochromatosis (HH) is treated by phlebotomy. It is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Hemochromatosis, Hyperferritinemia
- What is being tested?
- Venipuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 Jan 2023to 31 Mar 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:18-75 years
- Body weight > 50 Kg
- Haemoglobin ≥ 135 g/l (males), ≥ 125 g/l (females)
- In subjects of the HH and non-HH group: ferritin values >500 ng/ml, which must have been measured in the last three months before the inclusion in the study (either at the Blood Donation service or elsewhere), not followed by a blood donation or a phlebotomy
- In subjects of the HH group: genetic test demonstrating the presence of p.C282Y homozygous or p.C282Y/p.H63D compound heterozygous HFE-gene mutation
- In subjects of the control group: ferritin values < 300 ng/ml (males) or < 200 ng/ml (females)
- Written informed consent to the participation in the study
Who cannot join
- Inadequate vein access for whole blood collection
- Body weight < 50 kg
- Chronic viral infection (hepatitis B or C, HIV)
- Previous acute coronary heart disease
- Previous or current history of epilepsy
- Other severe conditions that could significantly increase the phlebotomy risk, based on individual medical evaluation
- No informed consent
- Pregnancy (according to the information on the standard blood donor questionnaire)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Blutspendedienst SRK beider Basel
Basel
Interregionale Blutspende SRK
Bern, 3008
About this study
Iron overload in hereditary hemochromatosis (HH) is treated by phlebotomy. It is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. The study investigates hemolysis and several other quality parameters of red blood cell concentrates (RBC) obtained from 80 individual with ferritin >500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control.
Read the detailed description
Iron overload in hereditary hemochromatosis is treated by phlebotomy. In Switzerland and in many other coutries, these individuals are not accepted for blood donation until ferritin values and phlebotomy intervals are in the normal range.
Individual with secondary hyperferritinemia, e. g. related to metabolic syndrome, are accepted as blood donors according to their clinical situation.
It is unclear if the quality of blood products issued from individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes is comparable with the quality of those issued from healthy blood donors, and if their characteristics comply with the international standards.
The study investigates the hemolysis rate and several other quality parameters in RBC obtained from 80 individual with ferritin >500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control. For this purpose, whole blood donations are manufactured according to the standard processes applied in the blood bank. Several standard quality parameters as well as biologic, rheologic, and oxydative stress-related variables are measured and compared, both with the current regulations and with those of the control group.
- Conditions
- Hereditary Hemochromatosis, Hyperferritinemia
- Being tested
- Venipuncture
- Medical subject headings
- Hemochromatosis, Hyperferritinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenipunctureProcedure or surgery
Bloodletting of 450 mL, followed by separation of the whole blood in 2 blood components: 1 red blood cell concentrate and 1 plasma. Measurement of the outcomes in the red blood cell concentrate.
| Study group | Role | What they receive |
|---|---|---|
| Hereditary hemochromatosis | Experimental | Individual with ferritin >500 ng/mL and documented homozygous or compound heterozygous HFE-gen mutation. Receives: Procedure: Venipuncture |
| secondary hyperferritinemia | Experimental | Individual with ferritin >500 ng/mL, not fulfilling the criteria for hereditary hemochromatosis. Receives: Procedure: Venipuncture |
| healthy blood donor with normal ferritin value. | Other | Healthy comparator. Receives: Procedure: Venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemolysis rate vs regulatory standards.
To verify that the hemolysis rate in % at the end of storage (day 42) of RBC from individuals with elevated ferritin is within the current accepted European standard of 0.8%.
Measured: After 42 days of storage
Secondary outcomes (3)
Hemolysis hyperferritinemia vs controls end of storage.
Comparison of haemolysis rate in % at day 42 in RBC from individuals with elevated ferritin of any cause and those with normal ferritin levels.
Measured: After 42 days of storage
Hemolysis hereditary hemochromatosis (HH) vs secondary hyperferritinemia entd of storage.
Comparisons of hemolysis rate in % at day 42 in RBC from individuals with HH and those with secondary hyperferritinemia.
Measured: After 42 days of storage
Hemolysis hyperferritinemia vs controls day 1.
Comparisons of hemolysis rate in % at day 1 in RBC from individuals with hyperferritinemia and those with normal ferritin.
Measured: After 42 days of storage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start18 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary HemochromatosisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective inclusion of individual and group allocation according to the collected clinical data and diagnoses.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Interregionale Blutspende SRK
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Fontana, Interregionale Blutspende SRK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742035
- Sponsor's protocol ID
- 2022-00274
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.
- ClinicalTrials.gov ID
- NCT05742035
- Acronym / sponsor ID
- 2022-00274
- Conditions
- Hereditary Hemochromatosis, Hyperferritinemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Interregionale Blutspende SRKUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 23 Feb 2023 (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.
Iron overload in hereditary hemochromatosis (HH) is treated by phlebotomy. It is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. The study investigates hemolysis and several other quality parameters of red blood cell concentrates (RBC) obtained from 80 individual with ferritin >500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control.
Detailed description
Iron overload in hereditary hemochromatosis is treated by phlebotomy. In Switzerland and in many other coutries, these individuals are not accepted for blood donation until ferritin values and phlebotomy intervals are in the normal range.
Individual with secondary hyperferritinemia, e. g. related to metabolic syndrome, are accepted as blood donors according to their clinical situation.
It is unclear if the quality of blood products issued from individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes is comparable with the quality of those issued from healthy blood donors, and if their characteristics comply with the international standards.
The study investigates the hemolysis rate and several other quality parameters in RBC obtained from 80 individual with ferritin >500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control. For this purpose, whole blood donations are manufactured according to the standard processes applied in the blood bank. Several standard quality parameters as well as biologic, rheologic, and oxydative stress-related variables are measured and compared, both with the current regulations and with those of the control group.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective inclusion of individual and group allocation according to the collected clinical data and diagnoses.
| Arm | Type | Receives |
|---|---|---|
| Hereditary hemochromatosis | Experimental | Procedure: VenipunctureIndividual with ferritin >500 ng/mL and documented homozygous or compound heterozygous HFE-gen mutation. |
| secondary hyperferritinemia | Experimental | Procedure: VenipunctureIndividual with ferritin >500 ng/mL, not fulfilling the criteria for hereditary hemochromatosis. |
| healthy blood donor with normal ferritin value. | Other | Procedure: VenipunctureHealthy comparator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age:18-75 years
- Body weight > 50 Kg
- Haemoglobin ≥ 135 g/l (males), ≥ 125 g/l (females)
- In subjects of the HH and non-HH group: ferritin values >500 ng/ml, which must have been measured in the last three months before the inclusion in the study (either at the Blood Donation service or elsewhere), not followed by a blood donation or a phlebotomy
- In subjects of the HH group: genetic test demonstrating the presence of p.C282Y homozygous or p.C282Y/p.H63D compound heterozygous HFE-gene mutation
Key exclusion criteria (8 listed)
- Inadequate vein access for whole blood collection
- Body weight < 50 kg
- Chronic viral infection (hepatitis B or C, HIV)
- Previous acute coronary heart disease
- Previous or current history of epilepsy
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 |
|---|---|---|
| VenipunctureBloodletting of 450 mL, followed by separation of the whole blood in 2 blood components: 1 red blood cell concentrate and 1 plasma. Measurement of the outcomes in the red blood cell concentrate. | Procedure or surgery | Hereditary hemochromatosis, healthy blood donor with normal ferritin value., secondary hyperferritinemia |
Primary outcome
Hemolysis rate vs regulatory standards.
Time frame: After 42 days of storage
To verify that the hemolysis rate in % at the end of storage (day 42) of RBC from individuals with elevated ferritin is within the current accepted European standard of 0.8%.
3 secondary outcomes
Hemolysis hyperferritinemia vs controls end of storage.
Time frame: After 42 days of storage
Hemolysis hereditary hemochromatosis (HH) vs secondary hyperferritinemia entd of storage.
Time frame: After 42 days of storage
Hemolysis hyperferritinemia vs controls day 1.
Time frame: After 42 days of storage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venipuncture in people with Hereditary Hemochromatosis and Hyperferritinemia, run by Interregionale Blutspende SRK at 2 sites in Switzerland.
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 7 inclusion and 8 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 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Hemolysis rate vs regulatory standards. (time frame: After 42 days of storage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2023.