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

Anemia Clinical Trial

— PREDICT-IVI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263571
• Other study ID #: 06-AnIt-18
• Status: Recruiting
• Start date: April 12, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: Goethe University
• Contact: Andrea U Steinbicker, Prof Dr MPH
• Phone: +49 69630186188
• Email: andrea.steinbicker[@]kgu.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• IV Iron

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt	Hessen
Germany	Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM	Muenster

Sponsors (3)

Lead Sponsor	Collaborator
Goethe University	Pharmacosmos A/S, University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of stay in the hospital	Length of stay in the hospital	Up to 12 weeks
Secondary	blood transfusions	Number of blood transfusions	Up to 12 weeks
Secondary	Diagnosis Related Groups (DRGs) related to infections	Diagnoses encoding infections	Up to 12 weeks
Secondary	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