Clinical trial NCT02087514: Duration of Red Blood Cell Storage Prior to Transfusion
Official title: Duration of Red Blood Cell Storage Prior to Transfusion and Non-Transferrin-Bound Iron
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron, Blood Level Abnormal
Keywords: Blood Transfusion
Iron
Red Blood Cells
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This study will determine the minimal duration of red blood cell (RBC) storage that leads to increases in circulating non-transferrin-bound iron in healthy human volunteers post-transfusion. The results from this study will help guide national guidelines for appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food and Drug Administration (FDA) criteria. The overall objective of this research is to improve the safety of refrigerated storage of red blood cells before transfusion.

Detailed description: Recent studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Red cells may be stored in a refrigerator prior to transfusion for up to 42 days by current FDA standards. Refrigerator storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased delivery of hemoglobin-iron to certain parts of the body. The investigators have preliminary data in mice and humans suggesting that delivery of a significant iron load from aged red cells leads to the production of a potentially toxic form of circulating iron called non-transferrin-bound iron.

In this prospective study of healthy volunteers, each subject will be randomized to receive transfusion of one RBC unit after 1, 2, 3, 4, 5, or 6 weeks of storage. The primary outcome will be the 24 hr area under the curve (AUC) of the serum non-transferrin bound iron concentration calculated from samples collected at 0, 2, 4, 6, 8, 10, 12, 14 and 24 hours after transfusion.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Body weight \>110 lbs
* Hemoglobin \>12.5 g/dL

Exclusion Criteria:

* Ineligible for donation based on the New York Blood Center blood donor questionnaire
* Systolic blood pressure \>180 or \<90 mm Hg, diastolic blood pressure \>100 or \<50 mm Hg
* Heart rate \<50 or \>100
* Temperature \>99.5 F prior to donation
* Temperature \>100.4 F or subjective feeling of illness prior to transfusion (this is to avoid having a concurrent illness affect post-transfusion measurements);
* Positive results on standard blood donor infectious disease testing
* Positive urine pregnancy test

Primary outcomes:
measure: Non-transferrin-bound Iron Level (AUC)
timeFrame: 0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Steven L Spitalnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rapido F, Brittenham GM, Bandyopadhyay S, La Carpia F, L'Acqua C, McMahon DJ, Rebbaa A, Wojczyk BS, Netterwald J, Wang H, Schwartz J, Eisenberger A, Soffing M, Yeh R, Divgi C, Ginzburg YZ, Shaz BH, Sheth S, Francis RO, Spitalnik SL, Hod EA. Prolonged red cell storage before transfusion increases extravascular hemolysis. J Clin Invest. 2017 Jan 3;127(1):375-382. doi: 10.1172/JCI90837. Epub 2016 Dec 12.