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A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

H

Haukeland University Hospital

Status

Terminated

Conditions

Anemia

Treatments

Other: Standard red blood cell transfusion
Other: Calculated red blood cell transfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01328262
2010/476

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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)..

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Hemoglobin dose
Experimental group
Description:
Intervention: Calculated red blood cell transfusion
Treatment:
Other: Calculated red blood cell transfusion
Standard treatment
Active Comparator group
Description:
Intervention: Standard red blood cell transfusion
Treatment:
Other: Standard red blood cell transfusion

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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