A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Sponsor

Haukeland University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01328262

Collaborator

(none)

Enrollment

Location

Arms

99.9

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Other: Calculated red blood cell transfusion Other: Standard red blood cell transfusion	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Actual Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Hemoglobin value [Less than 24 hours before transfusion and immediately after transfusion]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway

Sponsors and Collaborators

Haukeland University Hospital

Investigators

Principal Investigator: Tor A Hervig, Professor,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haukeland University Hospital

ClinicalTrials.gov Identifier:

NCT01328262

Other Study ID Numbers:

2010/476

First Posted:

Apr 4, 2011

Last Update Posted:

Aug 27, 2021

Last Verified:

Feb 1, 2019

Keywords provided by Haukeland University Hospital

Hemoglobins

Study Results

No Results Posted as of Aug 27, 2021