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NCT Number: NCT01319552

Fresh Versus Old Red Blood Cells for Transfusion

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.

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Key information

Conditions

Iron, Abnormal Blood Level Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Other Abnormal Blood Chemistry

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

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Fresh transfusion

Procedure

1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions

Other names: Stored transfusion

Old transfusion

Procedure

1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions

Other names: Stored transfusion

Primary outcomes

  1. Measure of Non-transferrin-bound Iron

    Time frame: four hours after transfusion

    Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

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

Registry information

Official study title

Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 21, 2011
Registry last updated
Jun 2, 2015

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.

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