N/A
N=79
Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality
Iron Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT02889133 ↗Enrolled (actual)
79
Serious AEs
1.3%
Results posted
Jun 2024
Primary outcome: Primary: 51-Chromium 24-hour Post-transfusion RBC Recovery of Units — 1.6; -0.4 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Iron-dextran (Drug); Saline (Drug); Blood Donation (Procedure); 24-hour PTR (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 51-Chromium 24-hour Post-transfusion RBC Recovery of Units |
1.6; -0.4 | — |
| SECONDARY RBC Zinc Protoporphyrin Levels |
54; 102 | — |
| SECONDARY Serum Ferritin |
25.1; 8.4 | — |
| SECONDARY Hemoglobin |
13.9; 11.2 | — |
| SECONDARY Reticulocyte Hemoglobin |
33.2; 29.0 | — |
| SECONDARY Soluble Transferrin Receptor |
3.6; 7.0 | — |
| SECONDARY Hepcidin |
20.3; 15.5 | — |
| SECONDARY Transferrin Saturation |
18.8; 9.1 | — |
| SECONDARY SF-36 Physical Functioning Score |
94.83; 94.87 | — |
| SECONDARY SF-36 Role Functioning/Physical Score |
91.29; 90.36 | — |
| SECONDARY SF-36 Role Functioning/Emotional Score |
85.58; 81.9 | — |
| SECONDARY SF-36 Energy/Fatigue Score |
65.94; 61.30 | — |
| SECONDARY SF-36 Emotional Well-being Score |
79.2; 76.7 | — |
| SECONDARY SF-36 Social Functioning Score |
90.7; 87.97 | — |
| SECONDARY SF-36 Pain Score |
86.9; 88.2 | — |
| SECONDARY SF-36 General Health Score |
80.3; 73.0 | — |
| SECONDARY SF-36 Health Change Score |
61.3; 54.6 | — |
| SECONDARY Beck Depression Inventory (BDI) II Score |
4.4; 4.8 | — |
| SECONDARY Beck Anxiety Inventory (BAI) Score |
3.7; 6.4 | — |
| SECONDARY Global Fatigue Index (GFI) Score |
11.0; 13.9 | — |
| SECONDARY Restless Legs Syndrome Rating Scale Score |
.48; 1.06 | — |
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 standards for clinical use.
Eligibility Criteria
Inclusion Criteria
- 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 =60 µmol/mol heme.
Exclusion Criteria
- 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 100 or 100;
- 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.
Data sourced from ClinicalTrials.gov (NCT02889133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.