Clinical trial NCT04263571: Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels
Official title: Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels Prior to Elective Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
IV Iron
Keywords: hemoglobin
hepcidin
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Pharmacosmos A/S
name: University Hospital Muenster
First posted: 2020-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with iron deficiency anemia prior to elective surgery

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).

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin level
timeFrame: 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.
Secondary outcomes:
measure: Hepcidin
timeFrame: 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.
measure: Serum iron
timeFrame: 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
measure: Transferrin saturation
timeFrame: 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
measure: Ferritin levels
timeFrame: 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
measure: Transferrin protein
timeFrame: 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
measure: Soluble transferrin receptor
timeFrame: 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
measure: Number of reticulocyte counts
timeFrame: 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
measure: Mean corpuscular hemoglobin (MCH)
timeFrame: 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
measure: Level of reticulocyte-Hb in g/dl
timeFrame: 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
measure: Level of Phosphate in serum
timeFrame: 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
measure: Corpuscular hemoglobin of reticulocytes (CHr)
timeFrame: 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
measure: Leucocyte count
timeFrame: 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
measure: Level of C-reactive Protein
timeFrame: 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
measure: Level of Serum Procalcitonin
timeFrame: 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
measure: Length of stay in the hospital
timeFrame: Up to 12 weeks
measure: blood transfusions
timeFrame: Up to 12 weeks
measure: Diagnosis Related Groups (DRGs) related to infections
timeFrame: Up to 12 weeks
measure: Correlation of hepcidin and IV iron parameters
timeFrame: 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
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
city: Muenster
country: Germany
facility: Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM
Study officials:
affiliation: Johann Wolfgang Goethe-University, Dept. of Anesthesiology, Intensive Care and Pain Medicine
name: Andrea U Steinbicker, Prof Dr MPH
role: PRINCIPAL_INVESTIGATOR
References: