Mean Reticulated Haemoglobin (Hb) Content (RetHe) Analysis of Renal Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
NHS Fife
University of Ulster
Information provided by:
NHS Tayside
ClinicalTrials.gov Identifier:
NCT01126905
First received: May 19, 2010
Last updated: June 4, 2010
Last verified: May 2010
  Purpose

Anaemia is a common complication of Chronic Kidney Disease (CKD) the management of which has been aided by the use of synthetic recombinant human erythropoietin therapy (r-HuEPO). This red cell stimulating agent creates the further complication of Functional Iron Deficiency (FID) where, despite normal iron stores, patients fail to respond to therapy as they do not possess enough available iron to meet the demand of increased red cell production. Effective response to r-HuEPO therapy depends on an appropriate monitoring of 'available' iron levels.

Previous research into the clinical utility of testing for reticulated haemoglobin concentrations (Ret He) instead of Serum Ferritin and Transferrin Saturation analysis has indicated an advantage as an iron deficient prognostic marker however, further knowledge is required on the use of this new laboratory test (RetHe) to predict Functional Iron Deficiency (FID) level and to study it's relationship with responses to therapy.

This proposed study aims to estimate a local working Normal (non deficient) and Iron Deficient Reticulated Haemoglobin Content (RET He) reference range from surplus anonamous samples. Routine monthly blood samples from Pre Dialysis and Haemodialysis patients will be used to evaluate the sensitivity and specificity of the RET He test compared to current laboratory tests and investigate its predictive ability for Functional Iron Deficiency in these patients.

Studying , measuring and statistically analysing the change in the RET He parameters in Haemodialysis and Pre Dialysis patients over 3 months will look for evidence of a direct relationship between RET He values and the patients response to therapy. The data will be used to provide a predictive picture of what levels of RET He indicate Functional Iron Deficiency.

The introduction of this test (RetHe) may provide clinicians with a one sample/one test control over iron therapies and ensure the patient gets the most benefit from erythropoietin therapy.


Condition
End-Stage Renal Failure
Functional Iron Deficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Local Pilot Evaluation of Laboratory Monitoring of Renal Patients on Erythropoietin and /or Iron Therapy Using Mean Reticulated Haemoglobin Equivalent (RetHe) and Their Response to Therapy

Resource links provided by NLM:


Further study details as provided by NHS Tayside:

Estimated Enrollment: 250
Study Start Date: June 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Renal Patients requested to participate in study (consent required)

Criteria

Inclusion Criteria:

  • Two groups of random routine anonamised blood samples (for use in determinimg a local normal range for the Reticulated Haemoglobin Content [RetHe])will be included in the study:

Normal red blood cell (RBC) Indices (Hb , Haematocrit, Mean Cell Volume ande Mean Cell Haemoglobin Content) ; an attempt will be made to select an equal mixture of men / women and an appropriate age spread to provide a valid control range for the group of test subjects (renal patients) The student Investigator will ask Haematology staff to record minimum details of iron deficient patients and "normal" test results noted at routine validation [positive identification number (barcode)/ age / sex] - these samples will be coded and additionally analysed for RetHe test.

Exclusion Criteria:

  • All renal patient who have had surgery and / or a Blood Transfusion OR bleeding episodes within the last month prior to the study are excluded as this would interfere with red cell parameters.

All patients < 16 years and >85 years are excluded from the study.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01126905

Sponsors and Collaborators
NHS Tayside
NHS Fife
University of Ulster
Investigators
Study Director: Raymond Robson NHS Fife Laboraories
Principal Investigator: PAMELA MARKS, BSc Hons. NHS Fife Area Laboratory
  More Information

No publications provided

Responsible Party: Ms Pamela Marks, NHS Fife Area Laboratories
ClinicalTrials.gov Identifier: NCT01126905     History of Changes
Other Study ID Numbers: 2010FAL1
Study First Received: May 19, 2010
Last Updated: June 4, 2010
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by NHS Tayside:
Reticulated Haemoglobin Equivalent
Functional Iron Deficiency
Response to therapy
Iron deficiency

Additional relevant MeSH terms:
Renal Insufficiency
Anemia, Iron-Deficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 22, 2014