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

NCT04631679 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2021-10-08

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Muenster, Institute of Inorganic and Analytical Chemistry

    collaborator UNKNOWN

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Andrea U Steinbicker, MD, MPH · Dept. of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Münster

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2021-04-29
Completion
2021-04-29

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631679 on ClinicalTrials.gov