Trial Outcomes & Findings for A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching (NCT NCT01328262)
NCT ID: NCT01328262
Last Updated: 2025-04-17
Results Overview
The change in hemoglobin concentration after transfusion was recorded. The change is defined as hemoglobin (g/dl) after transfusion minus hemoglobin (g/dl) before transfusion.
TERMINATED
NA
12 participants
Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded)
2025-04-17
Participant Flow
Patients were recruited from November 2010 to January 2011 in the outpatient medical clinic at Haukeland University Hospital
Participant milestones
| Measure |
Hemoglobin Dose
Intervention: Calculated red blood cell transfusion
Calculated red blood cell transfusion: The subjects receive an amount of red blood cells that has been calculated from their body surface area.
|
Standard Treatment
Intervention: Standard red blood cell transfusion
Standard red blood cell transfusion: The subjects in this group receive the prescribed number of red blood cell units.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hemoglobin Dose
n=6 Participants
Intervention: Calculated red blood cell transfusion
Calculated red blood cell transfusion: The subjects receive an amount of red blood cells that has been calculated from their body surface area.
|
Standard Treatment
n=6 Participants
Intervention: Standard red blood cell transfusion
Standard red blood cell transfusion: The subjects in this group receive the prescribed number of red blood cell units.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80 years
n=6 Participants
|
76 years
n=6 Participants
|
78 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Norway
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
|
Body Surface Area
|
1.81 m^2
n=6 Participants
|
1.75 m^2
n=6 Participants
|
1.78 m^2
n=12 Participants
|
|
Blood Volume
|
4.7 liter
n=6 Participants
|
4.4 liter
n=6 Participants
|
4.6 liter
n=12 Participants
|
PRIMARY outcome
Timeframe: Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded)The change in hemoglobin concentration after transfusion was recorded. The change is defined as hemoglobin (g/dl) after transfusion minus hemoglobin (g/dl) before transfusion.
Outcome measures
| Measure |
Hemoglobin Dose
n=6 Participants
Intervention: Calculated red blood cell transfusion
Calculated red blood cell transfusion: The subjects receive an amount of red blood cells with a hemoglobin content that has been calculated from their body surface area.
|
Standard Treatment
n=6 Participants
Intervention: Standard red blood cell transfusion
Standard red blood cell transfusion: The subjects in this group receive the prescribed number of red blood cell units.
|
|---|---|---|
|
Hemoglobin Concentration Change
|
1.8 g/dl
Interval 1.2 to 2.3
|
2.0 g/dl
Interval 1.8 to 2.2
|
Adverse Events
Hemoglobin Dose
Standard Treatment
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