UnknownPhase 4

Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery

Finland210 participantsStarted 2018-10-02

Plain-language summary

This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients presenting with cardiac disease requiring surgical operation
✓. Open heart surgery is considered the best appropriate treatment strategy according to the current guidelines.
✓. Have provided signed written informed consent

Exclusion criteria

✕. Age \< 35 years
✕. Patients requiring , emergency or salvage cardiac surgical operation
✕. Participation in another clinical study or treatment with another investigational product 30 days prior to randomization
✕. Moribund patient not expected to survive surgery 12 months after surgery
✕. Active malignant disease with a short life expectancy, not eligible for surgery
✕. Hemoglobin levels \> 155 g/dL for women and \>167 g/dl for men (upper reference limits for TYKSlab)
✕. Ferritin levels \>150 ug/l for women and \>400 ug/l for men.
✕. Renal dialysis therapy for chronic renal failure or severe preoperative renal impairment (eGFR\<30ml/min).

What they're measuring

Incidence of allogeneic blood transfusion and/or nosocomial infection

Timeframe: 0-90 days

Trial details

NCT IDNCT03574311

SponsorTurku University Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-12

Contact for this trial

Jarmo M Gunn, adj. professor

+35823130000 jarmo.gunn@tyks.fi

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