A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Anemia Clinical Trial

Official title:

A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01328262
• Other study ID #: 2010/476
• Status: Terminated
• Phase: N/A
• Start date: November 2010
• Est. completion date: March 2019

Study information

• Verified date: February 2019
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia

Intervention

Other:
• Calculated red blood cell transfusion
The subjects receive an amount of red blood cells that has been calculated from their body surface area.
• Standard red blood cell transfusion
The subjects in this group receive the prescribed number of red blood cell units.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin value	The investigators measure the hemoglobin levels before and after transfusion to see if the hemoglobin increment is as expected from the amount of red cells given.	Less than 24 hours before transfusion and immediately after transfusion