Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

Anemia Clinical Trial

Official title:

Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031289
• Other study ID #: IFA2012/IDCS
• Status: Completed
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac surgery. The study will answer the question of whether preoperative treatment of anemia or iron deficiency indeed improves transfusion needs (primary outcome) and important clinical outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of inclusion and exclusion criteria was deliberately chosen short so that this patient group largely reflects today's clinical practice .

• Trial with medical product

Description:

Anemic or iron deficiency patients are randomized into treatment and placebo groups. Treatment (see below) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3). The treatment will not be disclosed to the patient or the health care workers treating the patients during and after the operation.

Patients without anemia or iron deficiency will also be observed and the same postoperative measurements performed. They will serve as a natural comparison group.

Treatment:

Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml sodiumchloride (NaCl) over 30 min.

Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po.

The current transfusion and coagulation guidelines of the University Hospital of Zurich are followed in both groups identically. Postoperatively on the regular ward a Hb transfusion trigger of 80 g/L is applied

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients undergoing valve- and/or coronary bypass surgery

• Signed patient informed consent

• Only patients will be enrolled who won't have an emergency surgery on the same day

Exclusion criteria:

• Participation in another clinical trial within the last 4 weeks prior to enrollment

• Addiction or other disease that did not allow the patient to assess the nature, scope and possible consequences of the clinical tial

• Patients who do not sign the consent form or may not fully understand from inadequate knowledge of German.

• Patients who have not reached the age of legal majority

• Pregnant or lactating women

• Jehovah's Witnesses

• Patients with endocarditis

• Existing allergy or intolerance to ferric carboxymaltose or mannitol

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Drug:
• Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
Treatment ) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3). Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml NaCl over 30 min. Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Institute of Anaesthesiology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red blood cell (RBC) units transfused		7 days
Secondary	Percentage of patients without any RBC transfusions		90 days
Secondary	Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets)		90 days
Secondary	Length of stay in the intensive care unit (ICU)		90 days
Secondary	Duration of mechanical ventilation		90 days
Secondary	Acute kidney failure	RIFLE I, AKIN 2	7 days
Secondary	Major Adverse Cardiac and Cerebrovascular Events (MACCE)	Myocardial infarction, stroke, death	90 days
Secondary	New atrial fibrillation		90 days
Secondary	Infections	Pneumonia, hospital acquired Deep Sternal Wound Infection; Definition of infection: rise in inflammation markers after the initial postoperative period (acute phase reaction) and requires treatment and/ or prolongs days in hospital and/or microbiological confirmation of infection	7 days
Secondary	Thrombotic and thromboembolic complications (90 days)	clinical symptoms and evidence of thrombosis/ embolism in one of the following imaging methods (ultrasound, CT-scan)	90 days
Secondary	Length of stay (LOS) in the hospital		90 days
Secondary	Length of hospital stay (in comparison to median LOS published for relevant Swiss-DRGs)		90 days
Secondary	In hospital mortality		90 days
Secondary	30 day and 90-day mortality		90 days
Secondary	Costs (for blood products and pharmaceutical products related to transfusion and anemia management)	Comparison of costs for study medication versus costs for blood products and products related to transfusion	90 days
Secondary	Perioperative Hb concentrations		90 days
Secondary	Calculated RBC and blood loss		90 days
Secondary	Comparison of the treatment and placebo groups with the natural comparison group		90 days
Secondary	Safety and tolerance of administered study drug and placebo	Comparison of all serious adverse events between study drug group and placebo group	90 days