Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels

Study Overview
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Brief Summary
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The study is a multidisciplinary study, which involves all kind of medical specialties. Patients, who are scheduled for elective surgery, will be seen at a multidisciplinary anaesthesia/Patient Blood Management (PBM) clinic and screened for anaemia prior to surgery. Anaemic patients will eventually be treated with 500mg of iron isomaltoside.

Detailed Description
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Hgb levels, standard iron parameters and hepcidin will be assessed. Additional parameters that might influence Hgb or IVI levels will be documented. All main analyses will be pre-defined in detail in a statistical analysis plan. In order to analyse the responsiveness to IVI, the change in Hgb levels from PBM clinic to day 0 will be analysed using multivariable regression models. The association of change in Hgb and hepcidin will be analysed adjusting for potentially confounding factors as age, gender or number of days from PBM clinic to surgery. The correlation of hepcidin and standard iron parameters will be assessed. Based on the increase in Hgb levels, responders to IVI will be defined. The definition of good- bad responder in terms of delta Hgb levels depends on the time between IVI substitution and surgery. ROC analyses will be performed and potential predictors (e.g. hepcidin, ferritin) will be compared concerning the area under the ROC curve (AUC).

Official Title
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Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels Prior to Elective Surgery

Conditions
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Anemia, IV Iron

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent iron deficiency anemia elective surgery planned during the next 4 to 28 days Exclusion Criteria: Contraindications for an IV iron Infusion severe infections, hepatocellular carcinoma, liver metastases, acute severe asthma, a simultaneous oral iron medication, another IV iron preparation, iron overload, chronic renal failure and regular IV iron substitution Pregnancy or lactation Allergy against iron chronic renal failure on dialysis iron overload

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level | Change in hemoglobin level after IV iron treatment | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepcidin | Serum hepcidin level prior to IV iron Infusion (ng/ml) | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. | 
| Serum iron | Serum iron prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Transferrin saturation | Transferrin saturation prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Ferritin levels | Ferritin levels prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Transferrin protein | Transferrin protein prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Soluble transferrin receptor | Soluble transferrin receptor prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Number of reticulocyte counts | Number of reticulocyte counts | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Mean corpuscular hemoglobin (MCH) | Mean corpuscular hemoglobin prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Level of reticulocyte-Hb in g/dl | Level of reticulocyte-Hb prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Level of Phosphate in serum | Level of Phosphate in serum prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Corpuscular hemoglobin of reticulocytes (CHr) | Corpuscular hemoglobin of reticulocytes (CHr) prior to IV iron | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Value of each parameter prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Leucocyte count | Leucocyte count prior to IV iron Infusion | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. value prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Level of C-reactive Protein | Level of C-reactive Protein prior to IV iron Infusion | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. value prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Level of Serum Procalcitonin | Level of Serum Procalcitonin prior to IV iron Infusion | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. value prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 
| Length of stay in the hospital | Length of stay in the hospital | Up to 12 weeks | 
| blood transfusions | Number of blood transfusions | Up to 12 weeks | 
| Diagnosis Related Groups (DRGs) related to infections | Diagnoses encoding infections | Up to 12 weeks | 
| Correlation of hepcidin and IV iron parameters | Correlation of serum hepcidin and change of Hgb from baseline to day of surgery, day 1, 3 and 7 after surgery and the day of discharge | 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic. Correlation of values prior to IV iron infusion, prior to surgery, at day 1, 3 and 7 or day of release from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemoglobin, hepcidin