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

NCT04263571 | Unknown

• 1 other identifier: 06-AnIt-18
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Anemia; IV Iron

Keywords

hemoglobin; hepcidin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Hepcidin

  4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with iron deficiency anemia prior to elective surgery

You may qualify if:

• informed consent
• iron deficiency anemia
• elective surgery planned during the next 4 to 28 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead
• Pharmacosmos A/S: collaborator
• University Hospital Muenster: collaborator

Study Sites (2)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

NOT YET RECRUITING

Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM

Münster, 48149, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and serum samples

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Andrea U Steinbicker, Prof Dr MPH

  Johann Wolfgang Goethe-University, Dept. of Anesthesiology, Intensive Care and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea U Steinbicker, Prof Dr MPH

CONTACT

+49 69630186188; andrea.steinbicker@kgu.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Andrea Ulrike Steinbicker

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: February 11, 2020
• Study Start: April 12, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)