Fresh Versus Old Red Blood Cells for Transfusion

• ClinicalTrials.gov Identifier: NCT01319552
• Recruitment Status: Completed
• First Posted: March 21, 2011
• Results First Posted: June 2, 2015
• Last Update Posted: June 2, 2015
• Sponsor: Columbia University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Steven L. Spitalnik, Columbia University

Tracking Information

• First Submitted Date: March 18, 2011
• First Posted Date: March 21, 2011
• Results First Submitted Date: March 10, 2014
• Results First Posted Date: June 2, 2015
• Last Update Posted Date: June 2, 2015
• Study Start Date: December 2008
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2015)

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.

Original Primary Outcome Measures (submitted: March 18, 2011)

Measure of non-transferrin-bound iron [ Time Frame: Up to 72 hours after transfusion ]

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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fresh Versus Old Red Blood Cells for Transfusion
• Official Title: Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Iron, Abnormal Blood Level
• Other Abnormal Blood Chemistry

Intervention

• 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

Study Arms

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

  • Procedure: Fresh transfusion
  • Procedure: Old transfusion
• Experimental: Old transfusion
  1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
  Interventions:

  • Procedure: Fresh transfusion
  • Procedure: Old transfusion

• Publications *: Hod EA, Brittenham GM, Billote GB, Francis RO, Ginzburg YZ, Hendrickson JE, Jhang J, Schwartz J, Sharma S, Sheth S, Sireci AN, Stephens HL, Stotler BA, Wojczyk BS, Zimring JC, Spitalnik SL. Transfusion of human volunteers with older, stored red blood cells produces extravascular hemolysis and circulating non-transferrin-bound iron. Blood. 2011 Dec 15;118(25):6675-82. doi: 10.1182/blood-2011-08-371849. Epub 2011 Oct 20.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 15, 2015): 14
• Original Estimated Enrollment (submitted: March 18, 2011): 22
• Actual Study Completion Date: October 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01319552
• Other Study ID Numbers: AAAD3737; R01HL098014 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Steven L. Spitalnik, Columbia University
• Original Responsible Party: Steven Spitalnik, Columbia University Medical Center
• Current Study Sponsor: Columbia University
• Original Study Sponsor: Same as current
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Spitalnik L Spitalnik, MD; Columbia University

• PRS Account: Columbia University
• Verification Date: May 2015