Iron DeficiencyDIDSNCT02889133
Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality
A study testing Iron-dextran, Saline and Blood Donation in people with Iron Deficiency, run by Columbia University at 1 site in United States.
Trial summary
Primary Hypothesis The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet FDA standards for clinical use. The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron repletion will improve significantly and will meet FDA… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Iron-dextran, Saline and Blood Donation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 5 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18-75 years old;
- healthy (by self report);
- body weight >110 lbs;
- female hematocrit >=38%, male hematocrit >39%;
- frequent blood donor (men ≥2 and female ≥1 RBC unit donations in past year);
- ferritin <=15 ng/mL; and
- zinc protoporphyrin >=60 µmol/mol heme.
Who cannot join
- ineligible for donation based on the New York Blood Center donor autologous questionnaire;
- taking iron supplementation;
- C-reactive protein >10 mg/L;
- sickle cell trait;
- systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg;
- heart rate <50 or >100;
Show all 12Show fewer
- temperature >99.5°F prior to donation;
- temperature >100.4°F or subjective feeling of illness prior to 51-Chromium 24-hour RBC recovery study (to avoid the subject having a concurrent illness that may affect post-transfusion recovery);
- positive results on standard blood donor infectious disease testing;
- pregnancy;
- taking, or planning to take, iron supplements; and
- history of severe asthma requiring hospitalization, allergic eczema (atopic dermatitis), or other atopic allergy causing anaphylaxis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: A Randomized Trial to Determine if RBCs From Donors With Iron Deficient Erythropoiesis Have Decreased Post-transfusion RBC Recovery and Whether Iron Repletion Improves Recovery
Primary Hypothesis
- The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet FDA standards for clinical use.
- The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron repletion will improve significantly and will meet FDA standards for clinical use.
Read the detailed description
Iron deficiency is common among regular blood donors, but the recovery and quality of red blood cell (RBC) units from iron-deficient donors has not been rigorously examined. Evidence from both animal and human studies indicate that when the iron supply for erythropoiesis is inadequate, the RBCs produced have multiple metabolic defects that impair their ability to tolerate refrigerated storage. Studies in a mouse model demonstrated decreased post-transfusion recovery of refrigerator-stored RBCs obtained from iron-deficient donors. The planned studies will identify human donors at greatest risk of providing RBCs with poor post-transfusion recovery by using a combination of a decreased serum ferritin concentration and increased RBC zinc protoporphyrin, as described below. To evaluate unequivocally the role of iron deficiency in poor posttransfusion RBC recovery, intravenous iron will be used for iron repletion.
- Conditions
- Iron Deficiency
- Being tested
- Iron-dextran, Saline, Blood Donation, 24-hour PTR
- Keywords
- Iron deficiency, Transfusion, Blood donation
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-dextranDrug
Also called INFeD, Low molecular weight iron-dextran
Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline.
SalineDrug
Also called Placebo, Normal Saline
Salt water IV - 500 mL, one pint normal saline.
Blood DonationProcedure or surgery
Also called Red blood cell donation
Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution.
24-hour PTRProcedure or surgery
Also called 24-hour post-transfusion red cell recovery
The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation.
| Study group | Role | What they receive |
|---|---|---|
| Iron repletion | Active comparator | Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again, receive IV saline and undergo 24-hour PTR. Receives: Drug: Iron-dextran; Drug: Saline; Procedure: Blood Donation; Procedure: 24-hour PTR |
| Placebo | Placebo comparator | Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again, receive IV iron-dextran and undergo 24-hour PTR. Receives: Drug: Iron-dextran; Drug: Saline; Procedure: Blood Donation; Procedure: 24-hour PTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
51-Chromium 24-hour Post-transfusion RBC Recovery of Units
Comparison of the percentage change in 51-Chromium-labeled RBCs remaining from pre- and 24 hour post-transfusion measurement between the Iron Repletion and the Placebo group. The post-transfusion recovery represents the percent of 51-Chromium-labeled RBCs remaining in circulation 24 hours after infusion as compared to an extrapolated time zero measurement.
Measured: Performed 42 days after blood donation
Secondary outcomes (20)
RBC Zinc Protoporphyrin Levels
Measured in a clinical laboratory. Will be used to determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery along with the effect of treatment on zinc protoporphyrin levels.
Measured: End of participation (e.g., ~6 months)
Serum Ferritin
Measured in a clinical laboratory. Will be used to determine the association between pre-donation ferritin levels and post-transfusion recovery along with the effect of treatment on ferritin levels.
Measured: End of participation (e.g., ~6 months)
Hemoglobin
Measured in a clinical laboratory. Will be used to determine the association between pre-donation hemoglobin levels and post-transfusion recovery along with the effect of treatment on hemoglobin levels.
Measured: End of participation (e.g., ~6 months)
Reticulocyte Hemoglobin
Measured in a clinical laboratory. Will be used to determine the association between pre-donation reticulocyte hemoglobin levels and post-transfusion recovery along with the effect of treatment on reticulocyte hemoglobin levels.
Measured: End of participation (e.g., ~6 months)
Soluble Transferrin Receptor
Measured in a clinical laboratory. Will be used to determine the association between pre-donation soluble transferrin receptor levels and post-transfusion recovery along with the effect of treatment on soluble transferrin receptor levels.
Measured: End of participation (e.g., ~6 months)
Hepcidin
Measured as a research use only test in a research laboratory using an ELISA from Intrinsic LifeSciences. Will be used to determine the association between pre-donation hepcidin levels and post-transfusion recovery along with the effect of treatment on hepcidin levels.
Measured: End of participation (e.g., ~6 months)
Transferrin Saturation
Measured in a clinical laboratory. Will be used to determine the association between pre-donation transferrin saturation levels and post-transfusion recovery along with the effect of treatment on transferrin saturation levels.
Measured: End of participation (e.g., ~6 months)
SF-36 Physical Functioning Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
SF-36 Role Functioning/Physical Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
SF-36 Role Functioning/Emotional Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
SF-36 Energy/Fatigue Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
SF-36 Emotional Well-being Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
SF-36 Social Functioning Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
SF-36 Pain Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
SF-36 General Health Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
SF-36 Health Change Score
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Measured: End of participation (e.g., ~6 months)
Beck Depression Inventory (BDI) II Score
Evaluating subjects' depression using the Beck Depression Inventory-II survey. Scores range from 0-63 with higher scores indicating more severe depression.
Measured: End of participation (e.g., ~6 months)
Beck Anxiety Inventory (BAI) Score
Evaluating subjects' anxiety using the Beck Anxiety Inventory survey. Scores range from 0-63 with higher scores indicating more severe anxiety.
Measured: End of participation (e.g., ~6 months)
Global Fatigue Index (GFI) Score
Evaluating subjects' fatigue using the Multidimensional Assessment of Fatigue (MAF) survey. Scores range from 1-50 with higher scores indicating more severe fatigue.
Measured: End of participation (e.g., ~6 months)
Restless Legs Syndrome Rating Scale Score
Evaluating subjects' symptoms of restless leg syndrome using the Restless Legs Syndrome Rating Scale survey. Scores range from 0-40 with higher scores indicating more severe symptoms.
Measured: End of participation (e.g., ~6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJan 2017
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Blood Center, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Eldad Arie Hod, Columbia University
- Investigators
- Eldad A. Hod, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889133
- Sponsor's protocol ID
- AAAQ8875
- Other IDs
- 1R01HL133049-01
- Acronym
- DIDS
- Status last verified
- Jun 2024
- First submitted
- 25 Aug 2016
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Moroff G, Sohmer PR, Button LN. Proposed standardization of methods for determining the 24-hour survival of stored red cells. Transfusion. 1984 Mar-Apr;24(2):109-14. doi: 10.1046/j.1537-2995.1984.24284173339.x.
PubMed 6710582Hod EA, Brittenham GM, Bitan ZC, Feit Y, Gaelen JI, La Carpia F, Sandoval LA, Zhou AT, Soffing M, Mintz A, Schwartz J, Eng C, Scotto M, Caccappolo E, Habeck C, Stern Y, McMahon DJ, Kessler DA, Shaz BH, Francis RO, Spitalnik SL. A randomized trial of blood donor iron repletion on red cell quality for transfusion and donor cognition and well-being. Blood. 2022 Dec 22;140(25):2730-2739. doi: 10.1182/blood.2022017288.
PubMed 36069596Roussel C, Morel A, Dussiot M, Marin M, Colard M, Fricot-Monsinjon A, Martinez A, Chambrion C, Henry B, Casimir M, Volle G, Depond M, Dokmak S, Paye F, Sauvanet A, Le Van Kim C, Colin Y, Georgeault S, Roingeard P, Spitalnik SL, Ndour PA, Hermine O, Hod EA, Buffet PA, Amireault P. Rapid clearance of storage-induced microerythrocytes alters transfusion recovery. Blood. 2021 Apr 29;137(17):2285-2298. doi: 10.1182/blood.2020008563.
PubMed 33657208
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Determine if RBCs From Donors With Iron Deficient Erythropoiesis Have Decreased Post-transfusion RBC Recovery and Whether Iron Repletion Improves Recovery
- ClinicalTrials.gov ID
- NCT02889133
- Acronym / sponsor ID
- DIDS / AAAQ8875
- Conditions
- Iron Deficiency
- Keywords
- Iron deficiency, Transfusion, Blood donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- New York Blood Center, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2017 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Posted 12 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Hypothesis
- The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet FDA standards for clinical use.
- The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron repletion will improve significantly and will meet FDA standards for clinical use.
Detailed description
Iron deficiency is common among regular blood donors, but the recovery and quality of red blood cell (RBC) units from iron-deficient donors has not been rigorously examined. Evidence from both animal and human studies indicate that when the iron supply for erythropoiesis is inadequate, the RBCs produced have multiple metabolic defects that impair their ability to tolerate refrigerated storage. Studies in a mouse model demonstrated decreased post-transfusion recovery of refrigerator-stored RBCs obtained from iron-deficient donors. The planned studies will identify human donors at greatest risk of providing RBCs with poor post-transfusion recovery by using a combination of a decreased serum ferritin concentration and increased RBC zinc protoporphyrin, as described below. To evaluate unequivocally the role of iron deficiency in poor posttransfusion RBC recovery, intravenous iron will be used for iron repletion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron repletion | Active comparator | Drug: Iron-dextran, Drug: Saline, Procedure: Blood Donation, Procedure: 24-hour PTRSubjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again, receive IV saline and undergo 24-hour PTR. |
| Placebo | Placebo comparator | Drug: Iron-dextran, Drug: Saline, Procedure: Blood Donation, Procedure: 24-hour PTRSubjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again, receive IV iron-dextran and undergo 24-hour PTR. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years old;
- healthy (by self report);
- body weight >110 lbs;
- female hematocrit >=38%, male hematocrit >39%;
- frequent blood donor (men ≥2 and female ≥1 RBC unit donations in past year);
Key exclusion criteria (12 listed)
- ineligible for donation based on the New York Blood Center donor autologous questionnaire;
- taking iron supplementation;
- C-reactive protein >10 mg/L;
- sickle cell trait;
- systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg;
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 |
|---|---|---|
| Iron-dextranAlso: INFeD, Low molecular weight iron-dextranApproved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. | Drug | Iron repletion, Placebo |
| SalineAlso: Placebo, Normal SalineSalt water IV - 500 mL, one pint normal saline. | Drug | Iron repletion, Placebo |
| Blood DonationAlso: Red blood cell donationStandard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. | Procedure or surgery | Iron repletion, Placebo |
| 24-hour PTRAlso: 24-hour post-transfusion red cell recoveryThe way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. | Procedure or surgery | Iron repletion, Placebo |
Primary outcome
51-Chromium 24-hour Post-transfusion RBC Recovery of Units
Time frame: Performed 42 days after blood donation
Comparison of the percentage change in 51-Chromium-labeled RBCs remaining from pre- and 24 hour post-transfusion measurement between the Iron Repletion and the Placebo group. The post-transfusion recovery represents the percent of 51-Chromium-labeled RBCs remaining in circulation 24 hours after infusion as compared to an extrapolated time zero measurement.
20 secondary outcomes
RBC Zinc Protoporphyrin Levels
Time frame: End of participation (e.g., ~6 months)
Serum Ferritin
Time frame: End of participation (e.g., ~6 months)
Hemoglobin
Time frame: End of participation (e.g., ~6 months)
Reticulocyte Hemoglobin
Time frame: End of participation (e.g., ~6 months)
Soluble Transferrin Receptor
Time frame: End of participation (e.g., ~6 months)
Hepcidin
Time frame: End of participation (e.g., ~6 months)
Transferrin Saturation
Time frame: End of participation (e.g., ~6 months)
SF-36 Physical Functioning Score
Time frame: End of participation (e.g., ~6 months)
SF-36 Role Functioning/Physical Score
Time frame: End of participation (e.g., ~6 months)
SF-36 Role Functioning/Emotional Score
Time frame: End of participation (e.g., ~6 months)
SF-36 Energy/Fatigue Score
Time frame: End of participation (e.g., ~6 months)
SF-36 Emotional Well-being Score
Time frame: End of participation (e.g., ~6 months)
SF-36 Social Functioning Score
Time frame: End of participation (e.g., ~6 months)
SF-36 Pain Score
Time frame: End of participation (e.g., ~6 months)
SF-36 General Health Score
Time frame: End of participation (e.g., ~6 months)
SF-36 Health Change Score
Time frame: End of participation (e.g., ~6 months)
Beck Depression Inventory (BDI) II Score
Time frame: End of participation (e.g., ~6 months)
Beck Anxiety Inventory (BAI) Score
Time frame: End of participation (e.g., ~6 months)
Global Fatigue Index (GFI) Score
Time frame: End of participation (e.g., ~6 months)
Restless Legs Syndrome Rating Scale Score
Time frame: End of participation (e.g., ~6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6710582Moroff G, Sohmer PR, Button LN. Proposed standardization of methods for determining the 24-hour survival of stored red cells. Transfusion. 1984 Mar-Apr;24(2):109-14. doi: 10.1046/j.1537-2995.1984.24284173339.x.
- Derived from this study: PubMed 36069596Hod EA, Brittenham GM, Bitan ZC, Feit Y, Gaelen JI, La Carpia F, Sandoval LA, Zhou AT, Soffing M, Mintz A, Schwartz J, Eng C, Scotto M, Caccappolo E, Habeck C, Stern Y, McMahon DJ, Kessler DA, Shaz BH, Francis RO, Spitalnik SL. A randomized trial of blood donor iron repletion on red cell quality for transfusion and donor cognition and well-being. Blood. 2022 Dec 22;140(25):2730-2739. doi: 10.1182/blood.2022017288.
- Derived from this study: PubMed 33657208Roussel C, Morel A, Dussiot M, Marin M, Colard M, Fricot-Monsinjon A, Martinez A, Chambrion C, Henry B, Casimir M, Volle G, Depond M, Dokmak S, Paye F, Sauvanet A, Le Van Kim C, Colin Y, Georgeault S, Roingeard P, Spitalnik SL, Ndour PA, Hermine O, Hod EA, Buffet PA, Amireault P. Rapid clearance of storage-induced microerythrocytes alters transfusion recovery. Blood. 2021 Apr 29;137(17):2285-2298. doi: 10.1182/blood.2020008563.
- Individual participant dataSharing planned: No
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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.
Eldad A. Hod, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron-dextran, Saline and Blood Donation in people with Iron Deficiency, run by Columbia University at 1 site in United States.
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 12 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: finished, as of the sponsor's last update on 12 Jun 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
51-Chromium 24-hour Post-transfusion RBC Recovery of Units (time frame: Performed 42 days after blood donation). 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 NCT02889133, which also lists 3 linked publications.
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 12 Jun 2024.