A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Not Applicable

Terminated

• Conditions: Anemia
• Interventions: Other: Standard red blood cell transfusion; Other: Calculated red blood cell transfusion

• Registration Number: NCT01328262
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2010-11
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Status Verified: 2019-02
• Results First Submitted: 2025-03-21
• Results First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Results First Posted: 2025-04-17
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment	Standard red blood cell transfusion	Intervention: Standard red blood cell transfusion
Hemoglobin dose	Calculated red blood cell transfusion	Intervention: Calculated red blood cell transfusion

Primary Outcome Measures

Name	Time	Method
Hemoglobin Concentration Change	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.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway