PREDICT-IVI: Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels
Study Details
Study Description
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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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)
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Length of stay in the hospital [Up to 12 weeks]
Length of stay in the hospital
- blood transfusions [Up to 12 weeks]
Number of blood transfusions
- Diagnosis Related Groups (DRGs) related to infections [Up to 12 weeks]
Diagnoses encoding infections
- 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
Eligibility Criteria
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
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Allergy against iron
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chronic renal failure on dialysis
-
iron overload
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Frankfurt | Frankfurt | Hessen | Germany | 60590 |
| 2 | Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM | Muenster | Germany | 48149 |
Sponsors and Collaborators
- Goethe University
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 06-AnIt-18