A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

This study has suspended participant recruitment.
(Few patients, time consuming to find suiting blood bags with the "right" weight.)
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01328262
First received: February 24, 2011
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention
Anemia
Other: Red blood cells

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Hemoglobin value [ Time Frame: Less than 24 hours before transfusion and immediatly after transfusion ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemoglobin dose
The subjects in this group receive an amount red blood cells that has been calculated from the patients BSA.
Other: Red blood cells
The subjects receive an amount of RBC's that has been calculated from their BSA.
Other Names:
  • Hemoglobin content
  • RBC
Active Comparator: Standard treatment
The subjects in this group receive the prescribed number of red cell units.
Other: Red blood cells
The subjects in this group receive the prescribed number of redd blood cell units.
Other Names:
  • Hemoglobin content
  • RBC

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328262

Locations
Norway
Haukeland University Hospital
Bergen, Norway
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Tor A Hervig, Professor
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01328262     History of Changes
Other Study ID Numbers: 2010/476
Study First Received: February 24, 2011
Last Updated: May 2, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Hemoglobins

ClinicalTrials.gov processed this record on October 23, 2014