Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels (PREDICT-IVI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; IV Iron

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Andrea U Steinbicker, Prof Dr MPH; Phone Number: +49 69630186188; Email: andrea.steinbicker@kgu.de

Study Locations

• Germany
  • Muenster, Germany, 48149
    • Recruiting
    • Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM
    • Contact: Andrea U Steinbicker, MD, MPH; Phone Number: +49-251-47255; Email: andrea.steinbicker@ukmuenster.de
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Not yet recruiting
      • University Hospital Frankfurt
      • Contact: Andrea Steinbicker, Prof. Dr.; Email: andrea.steinbicker@kgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with iron deficiency anemia prior to elective surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: Pharmacosmos A/S; University Hospital Muenster
• Investigators: Principal Investigator: Andrea U Steinbicker, Prof Dr MPH, Johann Wolfgang Goethe-University, Dept. of Anesthesiology, Intensive Care and Pain Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: hemoglobin; hepcidin
• Other Study ID Numbers: 06-AnIt-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No