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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2011

Last Updated Date

May 2, 2012

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT01328262 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

Official Title ^ICMJE

A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Anemia

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01328262

Other Study ID Numbers ^ICMJE

2010/476

Has Data Monitoring Committee

Responsible Party

Haukeland University Hospital

Study Sponsor ^ICMJE

Haukeland University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tor A Hervig, Professor

Information Provided By

Haukeland University Hospital

Verification Date

May 2012

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

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