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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

February 24, 2011
May 2, 2012
November 2010
December 2012   (final data collection date for primary outcome measure)
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.
Hemoglobin value [ Time Frame: 1 year ] [ 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.
Complete list of historical versions of study NCT01328262 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching
A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Anemia
  • Other: Red blood cells
    The subjects receive an amount of RBC's that has been calculated from their BSA.
    Other Names:
    • Hemoglobin content
    • RBC
  • Other: Red blood cells
    The subjects in this group receive the prescribed number of redd blood cell units.
    Other Names:
    • Hemoglobin content
    • RBC
  • Experimental: Hemoglobin dose
    The subjects in this group receive an amount red blood cells that has been calculated from the patients BSA.
    Intervention: Other: Red blood cells
  • Active Comparator: Standard treatment
    The subjects in this group receive the prescribed number of red cell units.
    Intervention: Other: Red blood cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
June 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01328262
2010/476
No
Haukeland University Hospital
Haukeland University Hospital
Not Provided
Principal Investigator: Tor A Hervig, Professor
Haukeland University Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP