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| Name | Class |
|---|---|
| University of Muenster, Institute of Inorganic and Analytical Chemistry | UNKNOWN |
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The study is a pilot study, which involves cardiothoracic patients. Patients, who are scheduled for elective cardiosurgical procedure, will be seen in multidisciplinary anesthesia/Patient Blood Management (PBM) clinic and screened for anemia prior to surgery. Anemic patients will eventually be treated with 500mg of ferric carboxymaltose 1 to 4 days prior to surgery. A high blood loss is expected in these procedures (>500ml). Blood is collected and re-transfused to the patient via use of cell savers/ autologous blood restoration. The investigators will examine how fast intravenous ferric carboxymaltose is stored within the iron storage cells of the body, and how much remains within the patients blood at the time point of surgery. Next, the investigators will assess the wash out effect of iron via cell salvage. The hypothesis of this trial is that ferric carboxymaltose is washed out of the collected patient's blood by cell caver usage (Wash-Out Effect).
Because of the short time frame between iron therapy to procedure in cardiac surgery due to the need to perform cardiac revascularization, the investigators aim to investigate how much of the iron compound ferric carboxymaltose is being stored within the iron storage cells of the human body, and how much remains in the patient's own blood at the time point of surgery. The terminal elimination half-life time of ferric carboxymaltose is known to be approximately 7.1 to 12.1 hours, with peak serum ferritin levels at 48h to 120h after administration. When high blood loss in a surgical procedure is expected, such as in cardiosurgical procedures, the usage of autologous cell salvage, so called "Cell Saver", is considered standard, good practice. The blood that is lost during surgery is collected and after a specified blood separation wash, being retransfused in form of concentrated red blood cells.
This trial aims to examine whether Cell Saver usage might recover high molecular iron complexes such as ferric carboxymaltose lost by bleeding intraoperatively or wash out these molecules.
If amount of lost blood during surgery is too low, that Cell Saver usage would not be possible otherwise, averagely 300ml of blood from the heart-lung machine are added to the cell saver to enable the process of cell saver use.
For each participant, 7 samples will be taken. The samples include patient's blood samples and samples from cell saver compartments (Washing solution, concentrates) as well as from the heart-lung-machine, in detail:
By liquid chromatography inductively coupled plasma mass spectrometry (LC-ICP-MS) levels of ferric carboxymaltose are examined
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: anemic patients with iron treatment | For Group A anemic patients (hemoglobin levels below 13g/dL in men and 12g/dL in women) with iron deficiency (transferrin saturation below 20% or ferritin serum level below 300μg/L) are screened in the Anesthesia pre-assessment clinic 1-4 days prior to cardiosurgical procedure (valve repair/implementation, aortocoronary bypass or a combination of both) and are treated with a single intravenous dose of 500 milligrams of ferric carboxymaltose in 100ml 0,9% sodium chloride solution as iron supplementation directly (FerInject® 50 mg/ml, 10 ml, Vifor Pharma Group, Switzerland). | ||
| Group B: non-anemic patients without iron treatment | For Group B, non-anemic patients (hemoglobin levels above 13g/dL in men and 12g/dL in women) without iron deficiency (transferrin saturation above 20%, ferritin serum levels above 300μg/L) are screened in the Anesthesia pre-assessment clinic 1-4 days prior to cardiosurgical procedure (valve repair/implementation, aortocoronary bypass or both combined) and are not treated with iron supplementation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ferric Carboxymaltose levels (µg/mL) | Ferric Carboxymaltose levels in samples withdrawn from patient's blood, red blood cell concentrate of Cell Saver, heart-lung machine and washing solution prior to and after surgical procedure (µg/mL-Ferric carboxymaltose/plasma volume) | day of surgery to seven days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Donor red blood cell concentrates | Additional substitution of donor red blood cell concentrates | Beginning till end of surgery |
| Ferritin (ng/ml) | Ferritin levels before intravenous iron supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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A total of twenty-three patients undergoing elective cardiosurgical procedures (valve surgery, aortocoronary bypass or both combined) at University Hospital of Münster, Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea U Steinbicker, MD, MPH | Dept. of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Münster | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM | Münster | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36811991 | Derived | Olivier RMR, Macke M, Muller JC, Schrader L, Eveslage M, Rauer M, Wempe C, Martens S, Zarbock A, Wagner NM, Karst U, Dogan DY, Steinbicker AU. Perioperative Tracking of Intravenous Iron in Patients Undergoing On-Pump Cardiac Surgery: A Prospective, Single-Center Pilot Trial. Anesth Analg. 2023 Mar 1;136(3):578-587. doi: 10.1213/ANE.0000000000006372. Epub 2023 Feb 17. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
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Seven probes of patient's blood/serum, Cell Saver compounds or heart-lung machine are collected for each participant in Li-Heparin tubes (S-Monovette® 7,5ml Li-Heparin, Sarstedt AG & Co. KG, Nümbrecht, Germany) to examine ferric carboxymaltose levels in samples from different locations and time points.
| prior to intravenous iron supplementation |
| Ferritin (ng/ml) | Ferritin levels after intravenous iron supplementation | point of intravenous iron supplementation until surgery |
| Ferritin (ng/ml) | Ferritin levels after intravenous iron supplementation | 3 days after surgery |
| Ferritin (ng/ml) | Ferritin levels after intravenous iron supplementation | 7 days after surgery |
| Hemoglobin levels (mg/dl) | Delta Hemoglobin levels between prior to IV iron substitution until surgery | prior to intravenous iron supplementation, 1 to 4 days prior to surgery |
| Hemoglobin levels (mg/dl) | Hemoglobin levels after surgery | 3 days after surgery |
| Hemoglobin levels (mg/dl) | Hemoglobin levels after surgery | 7 days after surgery |
| Intraoperative blood loss (ml) | Blood volume lost while surgical procedure | Beginning till end of surgery |
| Blood volume balance (ml) | Delta of intraoperatively given (infusions, transfusions) and lost (bleeding, withdrawn from heart-lung machine) volumes | Beginning till end of surgery |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |