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

What Was Tested

In this phase 4 trial, researchers set out to test Cyanocobalamin (Vitamin B12) for anemia.

The researchers are performing the above prospective randomized trial in 1'000 patients undergoing cardiac surgery.

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.

It had three arms (groups): Anemia (active comparator), Iron deficiency (active comparator) and Natural comparison group (no intervention).

Patients without anemia or iron deficiency will be observed and the same postoperative measurements performed.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 1003 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the anemia participants stayed in one arm throughout.

Blinding on both sides kept the anemia participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-12 with completion listed for 2017-12.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Red blood cell (RBC) units transfused (time frame: 7 days).

It also tracked 18 secondary outcomes, for example Percentage of patients without any RBC transfusions, Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets), Length of stay in the intensive care unit (ICU), Duration of mechanical ventilation, Acute kidney failure and Major Adverse Cardiac and Cerebrovascular Events (MACCE).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 1003 people with anemia.

With 1003 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Anemia research.