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.
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).
Study Type
OBSERVATIONAL
Enrollment
100
University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany
NOT_YET_RECRUITINGDept. of Anesthesiology, Intensive Care and Pain Medicine, UKM
Münster, Germany
RECRUITINGHemoglobin level
Change in hemoglobin level after IV iron treatment
Time frame: 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.
Hepcidin
Serum hepcidin level prior to IV iron Infusion (ng/ml)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Soluble transferrin receptor
Soluble transferrin receptor prior to IV iron
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 12 weeks
blood transfusions
Number of blood transfusions
Time frame: Up to 12 weeks
Diagnosis Related Groups (DRGs) related to infections
Diagnoses encoding infections
Time frame: 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
Time frame: 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