Duration of Red Blood Cell Storage Prior to Transfusion

Not Applicable

Completed

• Conditions: Iron, Blood Level Abnormal
• Interventions: Procedure: Blood Transfusion; Other: Packed red blood cells

• Registration Number: NCT02087514
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2018-02-19
• Results First Submitted QC: 2018-02-19
• Status Verified: 2018-03
• Results First Posted: 2018-03-20
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Transfusion of PRBC stored for 1 week	Blood Transfusion	Subjects will receive blood transfusion with packed red blood cells stored for 1 week.
Transfusion of PRBC stored for 2 weeks	Blood Transfusion	Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.
Transfusion of PRBC stored for 3 weeks	Packed red blood cells	Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.
Transfusion of PRBC stored for 4 weeks	Packed red blood cells	Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.
Transfusion of PRBC stored for 2 weeks	Packed red blood cells	Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.
Transfusion of PRBC stored for 3 weeks	Blood Transfusion	Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.
Transfusion of PRBC stored for 4 weeks	Blood Transfusion	Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.
Transfusion of PRBC stored for 5 weeks	Blood Transfusion	Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.
Transfusion of PRBC stored for 5 weeks	Packed red blood cells	Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.
Transfusion of PRBC stored for 6 weeks	Blood Transfusion	Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.
Transfusion of PRBC stored for 1 week	Packed red blood cells	Subjects will receive blood transfusion with packed red blood cells stored for 1 week.
Transfusion of PRBC stored for 6 weeks	Packed red blood cells	Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Non-transferrin-bound Iron Level (AUC)	0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion	Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States