Anemia
Conditions
Keywords
Hemoglobins
Brief summary
The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused. Hypothesis: By matching the hemoglobin dose to the individual needs of the patient the investigators will reduce the total usage of red cell concentrates.
Detailed description
This is a randomized clinical study on hemoglobin dose and patient matching. The aim of the study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.
Interventions
OTHERCalculated red blood cell transfusion
The subjects receive an amount of red blood cells that has been calculated from their body surface area.
OTHERStandard red blood cell transfusion
The subjects in this group receive the prescribed number of red blood cell units.
Sponsors
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving red cell transfusions or expected to receive one or more red cell transfusions * Patients over 16 years of age * Patients for whom height and weight information is available * Patients who have consented to participate
Exclusion criteria
* Patients who are hemodynamically unstable (ongoing bleeding or hemolysis) * Patients with a known hemolytic anemia (congenital or acquired) * Patients with a positive Direct Antiglobulin Test (DAT) * Patients for whom informed consent has not been obtained * Patients where the hemoglobin concentration increment target is above 2g/dl. * Patients with auto- or alloantibodies against RBCs (red blood cells)..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Concentration Change | 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. |
Countries
Norway
Participant flow
Recruitment details
Patients were recruited from November 2010 to January 2011 in the outpatient medical clinic at Haukeland University Hospital
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Hemoglobin Dose | Standard Treatment | Total |
|---|---|---|---|
| Age, Continuous | 80 years | 76 years | 78 years |
| Blood Volume | 4.7 liter | 4.4 liter | 4.6 liter |
| Body Surface Area | 1.81 m^2 | 1.75 m^2 | 1.78 m^2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Norway | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Hemoglobin Concentration Change
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.
Time frame: Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hemoglobin Dose | Hemoglobin Concentration Change | 1.8 g/dl |
| Standard Treatment | Hemoglobin Concentration Change | 2.0 g/dl |