Trial Outcomes & Findings for Duration of Red Blood Cell Storage Prior to Transfusion (NCT NCT02087514)

NCT ID: NCT02087514

Last Updated: 2018-04-19

Results Overview

Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion

Results posted on

2018-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Transfusion of PRBC Stored for 1 Week Subjects will receive blood transfusion with packed red blood cells stored for 1 week. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 2 Weeks Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 3 Weeks Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 4 Weeks Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 5 Weeks Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 6 Weeks Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks
Overall Study STARTED	10	10	10	10	10	10
Overall Study COMPLETED	8	10	7	8	10	9
Overall Study NOT COMPLETED	2	0	3	2	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duration of Red Blood Cell Storage Prior to Transfusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transfusion of PRBC Stored for 1 Week n=8 Participants Subjects will receive blood transfusion with packed red blood cells stored for 1 week. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 2 Weeks n=10 Participants Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 3 Weeks n=7 Participants Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 4 Weeks n=8 Participants Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 5 Weeks n=10 Participants Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Transfusion of PRBC Stored for 6 Weeks n=9 Participants Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks	Total n=52 Participants Total of all reporting groups
Age, Continuous	25 years n=5 Participants	25 years n=7 Participants	28 years n=5 Participants	28 years n=4 Participants	28 years n=21 Participants	26 years n=10 Participants	27 years n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	20 Participants n=115 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	32 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	11 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants	8 Participants n=10 Participants	41 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	11 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	32 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Region of Enrollment United States	8 participants n=5 Participants	10 participants n=7 Participants	7 participants n=5 Participants	8 participants n=4 Participants	10 participants n=21 Participants	9 participants n=10 Participants	52 participants n=115 Participants

PRIMARY outcome

Timeframe: 0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion

Population: 52 out of the 60 enrolled subjects completed the study and were included in data analysis.

Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).