Duration of Red Blood Cell Storage Prior to Transfusion

NCT02087514 | Completed Results DMC

• 2 other identifiers: AAAI0835R01HL115557
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron, Blood Level Abnormal

Keywords

Blood Transfusion; Iron; Red Blood Cells

Outcome Measures

Primary Outcomes (1)

• Non-transferrin-bound Iron Level (AUC)

  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).

  0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion

Study Arms (6)

Transfusion of PRBC stored for 1 week

ACTIVE COMPARATOR

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

Procedure: Blood Transfusion; Other: Packed red blood cells

Transfusion of PRBC stored for 2 weeks

EXPERIMENTAL

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

Procedure: Blood Transfusion; Other: Packed red blood cells

Transfusion of PRBC stored for 3 weeks

EXPERIMENTAL

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

Procedure: Blood Transfusion; Other: Packed red blood cells

Transfusion of PRBC stored for 4 weeks

EXPERIMENTAL

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

Procedure: Blood Transfusion; Other: Packed red blood cells

Transfusion of PRBC stored for 5 weeks

EXPERIMENTAL

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

Procedure: Blood Transfusion; Other: Packed red blood cells

Transfusion of PRBC stored for 6 weeks

EXPERIMENTAL

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

Procedure: Blood Transfusion; Other: Packed red blood cells

Interventions

Blood Transfusion PROCEDURE

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

Also known as: Red blood cell (RBC) transfusion

Transfusion of PRBC stored for 1 week; Transfusion of PRBC stored for 2 weeks; Transfusion of PRBC stored for 3 weeks; Transfusion of PRBC stored for 4 weeks; Transfusion of PRBC stored for 5 weeks; Transfusion of PRBC stored for 6 weeks

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

Also known as: PRBC

Transfusion of PRBC stored for 1 week; Transfusion of PRBC stored for 2 weeks; Transfusion of PRBC stored for 3 weeks; Transfusion of PRBC stored for 4 weeks; Transfusion of PRBC stored for 5 weeks; Transfusion of PRBC stored for 6 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Body weight \>110 lbs
• Hemoglobin \>12.5 g/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 27941245 DERIVED

MeSH Terms

Interventions

Blood Transfusion; Erythrocyte Count

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Dr. Eldad Hod
• Organization: Columbia University Medical Center

eh2217@cumc.columbia.edu

(212) 342-5648

Study Officials

• Steven L Spitalnik, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pathology and Cell Biology

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 19, 2018
• Results First Posted: March 20, 2018

Record last verified: 2018-03

Locations

US (1)