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Few patients, difficult to find suiting blood bags with the "right" weight.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemoglobin dose | Experimental | Intervention: Calculated red blood cell transfusion |
|
| Standard treatment | Active Comparator | Intervention: Standard red blood cell transfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calculated red blood cell transfusion | Other | The subjects receive an amount of red blood cells that has been calculated from their body surface area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tor A Hervig, Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38780066 | Derived | Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3. |
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If other scientists want to conduct a similar study, we will provide information that are completely anonymized. We are not in contact with any other research group now.
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Patients were recruited from November 2010 to January 2011 in the outpatient medical clinic at Haukeland University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | g/dl | Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded) |
|
The adverse events were observed for 1 month after transfusion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemoglobin Dose | Intervention: Calculated red blood cell transfusion Calculated red blood cell transfusion: The amount of hemoglobin needed to increase the patients' hemoglobin to the desired level is calculated based on their body surface area and blood volume. Blood bags are chosen by weight to match this amount of hemoglobin. |
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The study was terminated after just a couple of months as it proved to be hard to provide blood bags matching the desired amount of hemoglobin in the study group. This was further complicated by blood group alloantibodies in the patients restricting the choice of blood bags.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elin Opheim Netland | Haukeland University Hospital | +4755976050 | elin.opheim.netland@helse-bergen.no |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2010 | Mar 1, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Standard red blood cell transfusion | Other | The subjects in this group receive the prescribed number of red blood cell units. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Surface Area | Mean | Full Range | m^2 |
|
| Blood Volume | Mean | Full Range | liter |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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