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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
研究概览
简要总结
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.
详细描述
Reference Range Testing for new test RET-He will be performed on excess blood available on randomly selected anonamised samples obtained from the daily workload of the laboratory once all the clinically requested analysis has been completed.
100 samples (50 men / 50 women)determined to have normal parameters(as defined by Dacie et al, 10th Edition) and 100 samples (50 men / 50 women)determined to be iron deficient (as defined by Dacie et al, 10th Edition)will be processed for new test parameter (RetHe) under a coded number to ensure no identifying data is recorded. The samples will be archived and and held within the lab for 24 hours prior to routine disposal in accordance with NHS Fife Waste Management Policy.The data will be analysed using a paired t test to determine significant differences and reference range inferred inferred.
Evaluation of sensitivity / specificity of new Ret He test in determinimg iron deficiency and functional iron deficiency and it's response to terapy will be tested using Haemodialysis and Pre-Dialysis Patient Samples (~180 Haemodialysis Patients and ~250 Pre Dialysis Patients)that are obtained during their normal renal unit / clinic appointments.
All consenting NHS Fife Haemodialysis /Pre Dialysis patients will be allocated a 'Subject Identification Number' as part of this study (which will be noted at the top of their Consent Form). This number will be used by the Student Investigator to generate a confidential Coding Key which will be kept separate from data information and secure uner an NHS password protected computer. This will ensure care of personal information and will be used through-out the study by the student investigator to record all generated data.
Patients will be grouped into categories such as Dialysis / Pre Dialysis on a coded SPSS (statistical software) file.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.