A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

April 14, 2025 updated by: Haukeland University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)..

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Concentration Change
Time Frame: 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.
Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Tor A Hervig, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (Estimated)

April 4, 2011

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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