Duration of Red Blood Cell Storage Prior to Transfusion

NCT ID: NCT02087514

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-02-29

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.

Conditions

Iron, Blood Level Abnormal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Transfusion of PRBC stored for 1 week

Subjects will receive blood transfusion with packed red blood cells stored for 1 week.

Group Type: ACTIVE_COMPARATOR

Blood Transfusion

Intervention Type: PROCEDURE

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

Packed red blood cells

Intervention Type: 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

Transfusion of PRBC stored for 2 weeks

Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.

Group Type: EXPERIMENTAL

Blood Transfusion

Intervention Type: PROCEDURE

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

Packed red blood cells

Intervention Type: 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

Transfusion of PRBC stored for 3 weeks

Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.

Group Type: EXPERIMENTAL

Blood Transfusion

Intervention Type: PROCEDURE

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

Packed red blood cells

Intervention Type: 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

Transfusion of PRBC stored for 4 weeks

Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.

Group Type: EXPERIMENTAL

Blood Transfusion

Intervention Type: PROCEDURE

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

Packed red blood cells

Intervention Type: 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

Transfusion of PRBC stored for 5 weeks

Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.

Group Type: EXPERIMENTAL

Blood Transfusion

Intervention Type: PROCEDURE

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

Packed red blood cells

Intervention Type: 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

Transfusion of PRBC stored for 6 weeks

Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.

Group Type: EXPERIMENTAL

Blood Transfusion

Intervention Type: PROCEDURE

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

Packed red blood cells

Intervention Type: 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

Interventions

Blood Transfusion

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

Intervention Type: PROCEDURE

Packed red blood cells

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

Intervention Type: OTHER

Other Intervention Names

Red blood cell (RBC) transfusion; PRBC

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Steven L. Spitalnik

Professor of Pathology and Cell Biology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven L Spitalnik, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27941245 (View on PubMed)

Other Identifiers

R01HL115557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAI0835

Identifier Type: -

Identifier Source: org_study_id