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

Phase 4

Completed

• Conditions: Anemia; Iron Deficiency
• Interventions: Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

• Registration Number: NCT02031289
• Lead Sponsor: University of Zurich

Brief 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

Detailed 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-09
• Primary Completion: 2017-12
• Status Verified: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1003

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anemia	Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid	Hb \< 120 g/L in women, Hb \< 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
Iron deficiency	Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid	ferritin \< 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Primary Outcome Measures

Name	Time	Method
Red blood cell (RBC) units transfused	7 days

Secondary Outcome Measures

Name	Time	Method
30 day and 90-day mortality	90 days
New atrial fibrillation	90 days
Infections	7 days	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
Length of stay (LOS) in the hospital	90 days
Acute kidney failure	7 days	RIFLE I, AKIN 2
Comparison of the treatment and placebo groups with the natural comparison group	90 days
Percentage of patients without any RBC transfusions	90 days
Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets)	90 days
Length of stay in the intensive care unit (ICU)	90 days
Duration of mechanical ventilation	90 days
Thrombotic and thromboembolic complications (90 days)	90 days	clinical symptoms and evidence of thrombosis/ embolism in one of the following imaging methods (ultrasound, CT-scan)
Safety and tolerance of administered study drug and placebo	90 days	Comparison of all serious adverse events between study drug group and placebo group
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	90 days	Myocardial infarction, stroke, death
Costs (for blood products and pharmaceutical products related to transfusion and anemia management)	90 days	Comparison of costs for study medication versus costs for blood products and products related to transfusion
Calculated RBC and blood loss	90 days
Length of hospital stay (in comparison to median LOS published for relevant Swiss-DRGs)	90 days
In hospital mortality	90 days
Perioperative Hb concentrations	90 days

Trial Locations

Locations (1)

University Hospital Zurich, Institute of Anaesthesiology; 🇨🇭 Zurich, ZH, Switzerland