Trial Outcomes & Findings for Effects of Transfusion of Older Stored Red Cells (NCT NCT01534676)
NCT ID: NCT01534676
Last Updated: 2016-10-05
Results Overview
TERMINATED
NA
3 participants
2 hours after transfusion
2016-10-05
Participant Flow
This is a research study carried out at Columbia University Medical Center. Participants with a blood disorder and currently receive blood transfusions as treatment will be transfused fresh, stored, washed or frozen blood according to regular schedule for up to 3 years. Volunteer dedicated donors will also be asked to provide consent.
Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment.
Participant milestones
| Measure |
Recipients
Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
|
Donors
Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Recipients
Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
|
Donors
Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
|
|---|---|---|
|
Overall Study
Study closed due to poor enrollment
|
2
|
1
|
Baseline Characteristics
Effects of Transfusion of Older Stored Red Cells
Baseline characteristics by cohort
| Measure |
Recipients
n=2 Participants
Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
|
Donors
n=1 Participants
Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 hours after transfusionPopulation: Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment. No data was collected or analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Recipients
Donors
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place