Fresh Versus Old Red Blood Cells for Transfusion

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven L. Spitalnik, Columbia University
ClinicalTrials.gov Identifier:
NCT01319552
First received: March 18, 2011
Last updated: May 15, 2015
Last verified: May 2015
  Purpose

Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. The investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. The investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.


Condition Intervention
Iron, Abnormal Blood Level
Other Abnormal Blood Chemistry
Procedure: Fresh transfusion
Procedure: Old transfusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Measure of Non-transferrin-bound Iron [ Time Frame: four hours after transfusion ] [ Designated as safety issue: No ]
    Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.


Enrollment: 14
Study Start Date: December 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fresh transfusion
1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
Procedure: Fresh transfusion
1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
Other Name: Stored transfusion
Procedure: Old transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Other Name: Stored transfusion
Experimental: Old transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Procedure: Fresh transfusion
1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
Other Name: Stored transfusion
Procedure: Old transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Other Name: Stored transfusion

Detailed Description:

Participants in this study will be asked to participate in a standard blood donation. The blood will be processed per standards at the investigators regional blood center (New York Blood Center) and then split into two equal units and shipped to Columbia University Medical Center for storage and transfusion. One unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after donation. Blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • male body weight >130 lbs, female body weight > 155 lbs
  • male height >5'1", female height >5'5"
  • hemoglobin >13.3 g/dL

Exclusion Criteria:

  • ineligible for donation based on the New York Blood Center autologous 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
  • positive results on standard blood donor infectious disease testing
  • pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319552

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Spitalnik L Spitalnik, MD Columbia University
  More Information

Publications:
Responsible Party: Steven L. Spitalnik, Professor of Pathology, Columbia University
ClinicalTrials.gov Identifier: NCT01319552     History of Changes
Other Study ID Numbers: AAAD3737, R01HL098014
Study First Received: March 18, 2011
Results First Received: March 10, 2014
Last Updated: May 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
red blood cells
transfusion
storage
sickle cell disease
β-thalassemia
hemoglobin-associated iron

ClinicalTrials.gov processed this record on August 03, 2015