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Completed

NCT Number: NCT02087514

Duration of Red Blood Cell Storage Prior to Transfusion

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Transfusion

Procedure

A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.

Other names: Red blood cell (RBC) transfusion

Packed red blood cells

Other

Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.

A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.

The number of weeks in storage are as follows:

  • 1 week
  • 2 weeks
  • 3 weeks
  • 4 weeks
  • 5 weeks
  • 6 weeks

Other names: PRBC

Primary outcomes

  1. Non-transferrin-bound Iron Level (AUC)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Duration of Red Blood Cell Storage Prior to Transfusion and Non-Transferrin-Bound Iron

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2014
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.