Overview

This trial is active, not recruiting.

Condition transfusion
Treatments fresh transfusion, old transfusion
Sponsor Columbia University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date December 2008
End date March 2011
Trial size 22 participants
Trial identifier NCT01319552, AAAD3737, R01HL098014

Summary

Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on 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. A participant 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Other)
fresh transfusion Stored transfusion
1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
old transfusion Stored transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
(Experimental)
fresh transfusion Stored transfusion
1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
old transfusion Stored transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions

Primary Outcomes

Measure
Measure of non-transferrin-bound iron
time frame: Up to 72 hours after transfusion

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion
Principal investigator Spitalnik L Spitalnik, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Columbia University.