---
title: Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.
nct_id: NCT02031289
overall_status: COMPLETED
phase: PHASE4
sponsor: University of Zurich
study_type: INTERVENTIONAL
primary_condition: Anemia
countries: Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02031289.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02031289"
ct_last_update_post_date: 2018-05-11
last_seen_at: "2026-05-12T06:50:36.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

**NCT ID:** [NCT02031289](https://clinicaltrials.gov/study/NCT02031289)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1003
- **Lead Sponsor:** University of Zurich
- **Conditions:** Anemia, Iron Deficiency
- **Start Date:** 2013-12
- **Completion Date:** 2018-05
- **CT.gov Last Update:** 2018-05-11

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Anemia** (ACTIVE_COMPARATOR) — Hb \< 120 g/L in women, Hb \< 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
- **Iron deficiency** (ACTIVE_COMPARATOR) — ferritin \< 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
- **Natural comparison group** (NO_INTERVENTION) — Patients without anemia or iron deficiency will be observed and the same postoperative measurements performed

## Interventions

- **Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid** (DRUG) — 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.

## Primary Outcomes

- **Red blood cell (RBC) units transfused** _(time frame: 7 days)_

## Secondary Outcomes

- **Percentage of patients without any RBC transfusions** _(time frame: 90 days)_
- **Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets)** _(time frame: 90 days)_
- **Length of stay in the intensive care unit (ICU)** _(time frame: 90 days)_
- **Duration of mechanical ventilation** _(time frame: 90 days)_
- **Acute kidney failure** _(time frame: 7 days)_
- **Major Adverse Cardiac and Cerebrovascular Events (MACCE)** _(time frame: 90 days)_
- **New atrial fibrillation** _(time frame: 90 days)_
- **Infections** _(time frame: 7 days)_
- **Thrombotic and thromboembolic complications (90 days)** _(time frame: 90 days)_
- **Length of stay (LOS) in the hospital** _(time frame: 90 days)_
- **Length of hospital stay (in comparison to median LOS published for relevant Swiss-DRGs)** _(time frame: 90 days)_
- **In hospital mortality** _(time frame: 90 days)_
- **30 day and 90-day mortality** _(time frame: 90 days)_
- **Costs (for blood products and pharmaceutical products related to transfusion and anemia management)** _(time frame: 90 days)_
- **Perioperative Hb concentrations** _(time frame: 90 days)_
- **Calculated RBC and blood loss** _(time frame: 90 days)_
- **Comparison of the treatment and placebo groups with the natural comparison group** _(time frame: 90 days)_
- **Safety and tolerance of administered study drug and placebo** _(time frame: 90 days)_

## Locations (1)

- University Hospital Zurich, Institute of Anaesthesiology, Zurich, Canton of Zurich, Switzerland

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospital zurich, institute of anaesthesiology|zurich|canton of zurich|switzerland` — added _(2026-05-12)_

---

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