Investigation of the Wash-out Effect of Intravenous Iron by Cell Savers (WASH-OUT)

NCT04631679 | Completed

• 1 other identifier: 09-Antl-19
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anemia; Anemia, Iron Deficiency; Iron Deficiency Anemia Treatment

Keywords

Anemia; Cell Saver; Iron Deficiency Anemia; Intravenous Iron; Ferric Carboxymaltose; Wash Out

Outcome Measures

Primary Outcomes (1)

• 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  Ferric Carboxymaltose levels in samples withdrawn from patient's blood, red blood cell concentrate of Cell Saver, heart-lung machine and washing solution prior to and after surgical procedure (µg/mL-Ferric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

Secondary Outcomes (10)

• Donor red blood cell concentrates

  Beginning till end of surgery

• Ferritin (ng/ml)

  prior to intravenous iron supplementation

• Ferritin (ng/ml)

  point of intravenous iron supplementation until surgery

• Ferritin (ng/ml)

  3 days after surgery

• Ferritin (ng/ml)

  7 days after surgery

Study Arms (2)

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.

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

A total of twenty-three patients undergoing elective cardiosurgical procedures (valve surgery, aortocoronary bypass or both combined) at University Hospital of Münster, Germany.

You may qualify if:

• scheduled cardiosurgical procedure such as valve surgery, aortocoronary bypass or both combined within 1-4 days after anesthesiological/PBM clinic
• for Group A: diagnosed anemia (hemoglobin levels below 13g/dL in men and 12g/dL in women) and iron-deficiency (transferrin saturation below 20% or ferritin serum level below 300μg/L), treatment with 500mg of ferric carboxymaltose (FerInject® 50 mg/ml, 10 ml, Vifor Pharma Group, Switzerland).

You may not qualify if:

• contraindication for intravenous iron therapy: severe infections, hepatocellular carcinoma, liver metastases, acute severe asthma, a simultaneous oral iron medication, another intravenous iron preparation, iron overload, chronic renal failure with regular intravenous iron substitution during dialysis treatment, age ≤18 years, pregnancy, lactation and being allergic to iron
• elevated C-reactive protein (CRP) and leukocyte levels (cut-off level for leucocytes for men was \<10.9x10\^3/μl and for women \<12.68x10\^3/μl, respectively)

Sponsors & Collaborators

• University Hospital Muenster: lead
• University of Muenster, Institute of Inorganic and Analytical Chemistry: collaborator

Study Sites (1)

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

Münster, 48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 36811991 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrea U Steinbicker, MD, MPH

  Dept. of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Münster

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: November 8, 2019
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

DE (1)