Clinical Trial: Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
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
Brief 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.
Detailed Summary: 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.
Sponsor: Columbia University
Current Primary Outcome: 51-Chromium 24-hour post-transfusion RBC recovery of units [ Time Frame: Performed 42 days after blood donation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- RBC zinc protoporphyrin levels (donation 1) [ Time Frame: Day 0 ]To determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery
- RBC zinc protoporphyrin levels (PTR 1) [ Time Frame: 42 days - after first blood donation ]To determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery
- RBC zinc protoporphyrin levels (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]To determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery
- RBC zinc protoporphyrin levels (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]To determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery
- ferritin (donation 1) [ Time Frame: Day 0 ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- ferritin (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- ferritin (PTR 1) [ Time Frame: 42 days - after first blood donation ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- ferritin (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- soluble transferrin receptor (donation 1) [ Time Frame: Day 0 ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- soluble transferrin receptor (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- soluble transferrin receptor (PTR 1) [ Time Frame: 42 days - after first blood donation ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- soluble transferrin receptor (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- hepcidin (donation 1) [ Time Frame: Day 0 ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- hepcidin (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- hepcidin (PTR 1) [ Time Frame: 42 days - after first blood donation ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- hepcidin (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status
- Cognitive Function Composite Score (donation 1) [ Time Frame: Day 0 ]NIH toolbox neurocognitive assessments will be performed to assess effects of iron repletion on these scores.
- Cognitive Function Composite Score (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]NIH toolbox neurocognitive assessments will be performed to assess effects of iron repletion on these scores.
- Cognitive Function Composite Score (PTR 1) [ Time Frame: 42 days - after first blood donation ]NIH toolbox neurocognitive assessments will be performed to assess effects of iron repletion on these scores.
- Cognitive Function Composite Score (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]NIH toolbox neurocognitive assessments will be performed t
Original Secondary Outcome: Same as current
Information By: Columbia University
Dates:
Date Received: August 25, 2016
Date Started: January 2017
Date Completion: April 2021
Last Updated: March 20, 2017
Last Verified: March 2017
