Trial Outcomes & Findings for Fresh Versus Old Red Blood Cells for Transfusion (NCT NCT01319552)
NCT ID: NCT01319552
Last Updated: 2015-06-02
Results Overview
Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
four hours after transfusion
Results posted on
2015-06-02
Participant Flow
The recruitment of volunteers began in December 2008 and ended in October 2010. All the volunteers were recruited at Columbia University.
Participant milestones
| Measure |
Transfusion
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
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fresh Versus Old Red Blood Cells for Transfusion
Baseline characteristics by cohort
| Measure |
Transfusion
n=14 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: four hours after transfusionComparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.
Outcome measures
| Measure |
Fresh Transfusion
n=14 Participants
Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
|
Old Transfusion
n=14 Participants
Old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
|
|---|---|---|
|
Measure of Non-transferrin-bound Iron
|
0.16 μM
Standard Deviation 0.99
|
3.17 μM
Standard Deviation 3.26
|
Adverse Events
Transfusion
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transfusion
n=14 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place