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

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Iron, Abnormal Blood Level; Other Abnormal Blood Chemistry
• Interventions: Procedure: Fresh transfusion; Procedure: Old transfusion
• Enrollment: 14

Participant Flow

Recruitment Details	The recruitment of volunteers began in December 2008 and ended in October 2010. All the volunteers were recruited at Columbia University.
Pre-assignment Details

Arm/Group Title	Transfusion
Arm/Group Description	Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Period Title: Overall Study
Started	14
Completed	14
Not Completed	0

Baseline Characteristics

Arm/Group Title		Transfusion
Arm/Group Description		Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Old transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Overall Number of Baseline Participants		14
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	14 100.0%
	>=65 years	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants
	Female	4 28.6%
	Male	10 71.4%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants
	Hispanic or Latino	2 14.3%
	Not Hispanic or Latino	12 85.7%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants
	American Indian or Alaska Native	0 0.0%
	Asian	2 14.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	1 7.1%
	White	11 78.6%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	14 participants
		14

Outcome Measures

1. Primary Outcome

Title	Measure of Non-transferrin-bound Iron
Description	Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.
Time Frame	four hours after transfusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fresh Transfusion	Old Transfusion
Arm/Group Description:	Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions	Old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: μM
	0.16 (0.99)	3.17 (3.26)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Transfusion
Arm/Group Description	Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
All-Cause Mortality
	Transfusion
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Transfusion
	Affected / at Risk (%)	# Events
Total	0/14 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Transfusion
	Affected / at Risk (%)	# Events
Total	3/14 (21.43%)
Gastrointestinal disorders
Nausea * [1]	2/14 (14.29%)	2
Nervous system disorders
Headache *	1/14 (7.14%)	1
* Indicates events were collected by non-systematic assessment; [1] Vasovagal at time of donation

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Steven Spitalnik
• Organization: Columbia University
• Phone: 2123425648
• EMail: eldad.hod@gmail.com

Publications of Results:

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.

• Responsible Party: Steven L. Spitalnik, Columbia University
• ClinicalTrials.gov Identifier: NCT01319552
• Other Study ID Numbers: AAAD3737; R01HL098014 ( U.S. NIH Grant/Contract )
• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Results First Submitted: March 10, 2014
• Results First Posted: June 2, 2015
• Last Update Posted: June 2, 2015