A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

NCT01328262 | Terminated Results

• 1 other identifier: 2010/476
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

Hemoglobins

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Concentration Change

  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)

Study Arms (2)

Hemoglobin dose

EXPERIMENTAL

Intervention: Calculated red blood cell transfusion

Other: Calculated red blood cell transfusion

Standard treatment

ACTIVE COMPARATOR

Intervention: Standard red blood cell transfusion

Other: Standard red blood cell transfusion

Interventions

Calculated red blood cell transfusion OTHER

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

Hemoglobin dose

Standard red blood cell transfusion OTHER

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

Standard treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)..

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (1)

• Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

  PMID: 38780066 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

The study was terminated after just a couple of months as it proved to be hard to provide blood bags matching the desired amount of hemoglobin in the study group. This was further complicated by blood group alloantibodies in the patients restricting the choice of blood bags.

Results Point of Contact

• Title: Elin Opheim Netland
• Organization: Haukeland University Hospital

elin.opheim.netland@helse-bergen.no

+4755976050

Study Officials

• Tor A Hervig, Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: April 4, 2011
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)