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

• Conditions: IV Iron; Anemia

• Registration Number: NCT04263571
• Lead Sponsor: Goethe University

Brief Summary

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

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 Timeline

• Study Start: 2019-04-12
• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-08
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.	Change in hemoglobin level after IV iron treatment

Secondary Outcome Measures

Name	Time	Method
Serum 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	Serum iron prior to IV iron
Ferritin levels	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 prior to IV iron
Level of Phosphate in serum	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 prior to IV iron
Hepcidin	4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.	Serum hepcidin level prior to IV iron Infusion (ng/ml)
Level of reticulocyte-Hb in g/dl	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 prior to IV iron
Corpuscular hemoglobin of reticulocytes (CHr)	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) prior to IV iron
Level of C-reactive Protein	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 prior to IV iron Infusion
Level of Serum Procalcitonin	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 prior to IV iron Infusion
Transferrin saturation	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 prior to IV iron
Soluble transferrin receptor	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 prior to IV iron
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	Number of reticulocyte counts
Leucocyte count	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	Leucocyte count prior to IV iron Infusion
Transferrin protein	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 prior to IV iron
Length of stay in the hospital	Up to 12 weeks	Length of stay in the hospital
Correlation of hepcidin and IV iron parameters	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	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
Mean corpuscular hemoglobin (MCH)	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 prior to IV iron
blood transfusions	Up to 12 weeks	Number of blood transfusions
Diagnosis Related Groups (DRGs) related to infections	Up to 12 weeks	Diagnoses encoding infections

Trial Locations

Locations (2)

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany

Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM; 🇩🇪 Muenster, Germany