AnemiaPREDICT-IVINCT04263571
Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels
An observational study of Anemia and IV Iron, run by Goethe University at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- 12 Apr 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with iron deficiency anemia prior to elective surgery
Who may be able to join
- informed consent
- iron deficiency anemia
- elective surgery planned during the next 4 to 28 days
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Not yet recruiting
University Hospital Frankfurt
Frankfurt am Main, Hesse, 60590
Andrea Steinbicker, Prof. Dr., andrea.steinbicker@kgu.de
- Recruiting
Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM
Münster, 48149
Andrea U Steinbicker, MD, MPH, +49-251-47255, andrea.steinbicker@ukmuenster.de
About this study
Official title: 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.
Read the 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).
- Keywords
- hemoglobin, hepcidin
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Change in hemoglobin level after IV iron treatment
Measured: 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.
Secondary outcomes (18)
Hepcidin
Serum hepcidin level prior to IV iron Infusion (ng/ml)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 12 weeks
blood transfusions
Number of blood transfusions
Measured: Up to 12 weeks
Diagnosis Related Groups (DRGs) related to infections
Diagnoses encoding infections
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start12 Apr 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacosmos A/S, University Hospital Muenster
- Responsible party
- Principal investigator, Priv.-Doz. Dr. Andrea Ulrike Steinbicker, Goethe University
- Investigators
- Andrea U Steinbicker, Prof Dr MPH, Principal investigator, Johann Wolfgang Goethe-University, Dept. of Anesthesiology, Intensive Care and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263571
- Sponsor's protocol ID
- 06-AnIt-18
- Acronym
- PREDICT-IVI
- Status last verified
- Sep 2021
- First submitted
- 30 Aug 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels Prior to Elective Surgery
- ClinicalTrials.gov ID
- NCT04263571
- Acronym / sponsor ID
- PREDICT-IVI / 06-AnIt-18
- Keywords
- hemoglobin, hepcidin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Pharmacosmos A/S, University Hospital Muenster
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with iron deficiency anemia prior to elective surgery
Key inclusion criteria (3 listed)
- informed consent
- iron deficiency anemia
- elective surgery planned during the next 4 to 28 days
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemoglobin level
Time frame: 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
18 secondary outcomes
Hepcidin
Time frame: 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.
Serum iron
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 12 weeks
blood transfusions
Time frame: Up to 12 weeks
Diagnosis Related Groups (DRGs) related to infections
Time frame: Up to 12 weeks
Correlation of hepcidin and IV iron parameters
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea U Steinbicker, Prof Dr MPH principal investigator
Johann Wolfgang Goethe-University, Dept. of Anesthesiology, Intensive Care and Pain Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and IV Iron, run by Goethe University at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea U Steinbicker, Prof Dr MPH (+49 69630186188, andrea.steinbicker@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level (time frame: 4-28 days prior to elective surgery, IV iron is infused in the anesthesia pre-assessment clinic.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.