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Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial
- Source :
- Lancet (London, England). 393(10187)
- Publication Year :
- 2018
-
Abstract
- Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. This study assessed whether immediate preoperative treatment could result in reduced perioperative red blood cell (RBC) transfusions and improved outcome.In this single-centre, randomised, double-blind, parallel-group controlled study, patients undergoing elective cardiac surgery with anaemia (n=253; haemoglobin concentration (Hb)120 g/L in women and Hb130 g/L in men) or isolated iron deficiency (n=252; ferritin100 mcg/L, no anaemia) were enrolled. Participants were randomly assigned (1:1) with the use of a computer-generated range minimisation (allocation probability 0·8) to receive either placebo or combination treatment consisting of a slow infusion of 20 mg/kg ferric carboxymaltose, 40 000 U subcutaneous erythropoietin alpha, 1 mg subcutaneous vitamin B12, and 5 mg oral folic acid or placebo on the day before surgery. Primary outcome was the number of RBC transfusions during the first 7 days. This trial is registered with ClinicalTrials.gov, number NCT02031289.Between Jan 9, 2014, and July 19, 2017, 1006 patients were enrolled; 505 with anaemia or isolated iron deficiency and 501 in the registry. The combination treatment significantly reduced RBC transfusions from a median of one unit in the placebo group (IQR 0-3) to zero units in the treatment group (0-2, during the first 7 days (odds ratio 0·70 [95% CI 0·50-0·98] for each threshold of number of RBC transfusions, p=0·036) and until postoperative day 90 (p=0·018). Despite fewer RBC units transfused, patients in the treatment group had a higher haemoglobin concentration, higher reticulocyte count, and a higher reticulocyte haemoglobin content during the first 7 days (p≤0·001). Combined allogeneic transfusions were less in the treatment group (0 [IQR 0-2]) versus the placebo group (1 [0-3]) during the first 7 days (p=0·038) and until postoperative day 90 (p=0·019). 73 (30%) serious adverse events were reported in the treatment group group versus 79 (33%) in the placebo group.An ultra-short-term combination treatment with intravenous iron, subcutaneous erythropoietin alpha, vitamin B12, and oral folic acid reduced RBC and total allogeneic blood product transfusions in patients with preoperative anaemia or isolated iron deficiency undergoing elective cardiac surgery.Vifor Pharma and Swiss Foundation for Anaesthesia Research.
- Subjects :
- Male
medicine.medical_specialty
Time Factors
Heart Diseases
Anemia
Administration, Oral
030204 cardiovascular system & hematology
Ferric Compounds
law.invention
03 medical and health sciences
0302 clinical medicine
Folic Acid
Randomized controlled trial
Double-Blind Method
law
Preoperative Care
medicine
Humans
030212 general & internal medicine
Prospective Studies
Cardiac Surgical Procedures
Adverse effect
Prospective cohort study
Maltose
Erythropoietin
Aged
Aged, 80 and over
Anemia, Iron-Deficiency
business.industry
General Medicine
Perioperative
Iron deficiency
Odds ratio
Middle Aged
medicine.disease
Cardiac surgery
Vitamin B 12
Anesthesia
Administration, Intravenous
Drug Therapy, Combination
Female
business
Erythrocyte Transfusion
Subjects
Details
- ISSN :
- 1474547X
- Volume :
- 393
- Issue :
- 10187
- Database :
- OpenAIRE
- Journal :
- Lancet (London, England)
- Accession number :
- edsair.doi.dedup.....5afa3bc92f66b9788e7aa1f912fafe6d