Public university conducts investigationof the wash-out effect of Intravenous Iron by Cell Savers
Photo by Max Muselmann
The University Hospital Muenster is conducting the Investigation of the Wash-out Effect of Intravenous Iron by Cell Savers.
The University of Münster is a public university located in the city of Münster, North Rhine-Westphalia in Germany.
The study is a study, which involves cardiothoracic patients. Patients, who are scheduled for the elective cardiosurgical procedure, will be seen to our multidisciplinary anaesthesia/Patient Blood Management (PBM) clinic and screened for anaemia prior to surgery. Anaemic patients will eventually be treated with 500mg of ferric carboxymaltose 1 to 4 days prior to surgery. The researchers will investigate how fast intravenousferric 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, they will examine 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, they aim to investigate how much of the iron compound ferric carboxymaltose is been 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. 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.
Actual study start date is September 30, 2019. The researchers expect to complete the study by February 28, 2021.
Among study population are a total of twenty patients undergoing elective cardiosurgical procedures (valve surgery, aortocoronary bypass or both combined) at University Hospital of Münster, Germany.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04631679) Dept. of Anesthesiology, Intensive Care and Pain Medicine, UKM (Muenster, Germany).
