A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Conditions
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Anemia

Intervention / Treatment
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* Other: Calculated red blood cell transfusion
* Other: Standard red blood cell transfusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemoglobin dose<br>Intervention: Calculated red blood cell transfusion | Other: Calculated red blood cell transfusion<br>* The subjects receive an amount of red blood cells that has been calculated from their body surface area.<br>|
| Active Comparator: Standard treatment<br>Intervention: Standard red blood cell transfusion | Other: Standard red blood cell transfusion<br>* The subjects in this group receive the prescribed number of red blood cell units.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin value | The investigators measure the hemoglobin levels before and after transfusion to see if the hemoglobin increment is as expected from the amount of red cells given. | Less than 24 hours before transfusion and immediately after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemoglobins