A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

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.

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Hemoglobin dose

Intervention: Calculated red blood cell transfusion

Group Type EXPERIMENTAL

Calculated red blood cell transfusion

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Standard red blood cell transfusion

Intervention Type OTHER

The subjects in this group receive the prescribed number of red blood cell units.

Interventions

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Calculated red blood cell transfusion

The subjects receive an amount of red blood cells that has been calculated from their body surface area.

Intervention Type OTHER

Standard red blood cell transfusion

The subjects in this group receive the prescribed number of red blood cell units.

Intervention Type OTHER

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 (red blood cells)..

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No