Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery

NCT03574311 | Unknown Phase 4 DMC

• 1 other identifier: PREFER-CPB01
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.

Conditions

Coronary Artery Disease; Postoperative Complications; Aortic Valve Stenosis; Mitral Valve Disease; Aortic Aneurysm, Thoracic

Keywords

CABG; cardiac surgery; blood transfusion; intravenous iron; postoperative infection

Outcome Measures

Primary Outcomes (1)

• Incidence of allogeneic blood transfusion and/or nosocomial infection

  Composite of transfused red blood cell units and/or nosocomial infection

  0-90 days

Secondary Outcomes (11)

• Mortality

  0-90 days

• ICU/CCU days

  0-90 days

• Perioperative myocardial infarction

  3 days

• Length of stay

  0-90 days

• Days on vasoactive drugs

  0-90 days

Study Arms (2)

Ferric carboxymaltose

EXPERIMENTAL

Preoperative 1000 mg intravenous single dose as 30 minute infusion

Drug: Ferric carboxymaltose

Placebo

PLACEBO COMPARATOR

Preoperative 100 ml saline as 30 minute infusion

Other: Physiological saline

Interventions

Ferric carboxymaltose DRUG

A single dose of drug or placebo is administered preoperatively to participants

Ferric carboxymaltose

Physiological saline OTHER

Single infusion 100 ml physiological saline infusion preoperatively

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with cardiac disease requiring surgical operation
• Open heart surgery is considered the best appropriate treatment strategy according to the current guidelines.
• significant three vessel disease
• left main disease ± single, two or three vessel disease
• two-vessel disease with proximal LAD stenosis
• coronary artery disease requiring revascularization not amenable to percutaneous coronary intervention
• Aortic valve disease requiring aortic valve surgery
• Mitral valve disease requiring surgical mitral surgery
• Combined surgery for revascularization and valve disease
• surgery of ascending aorta
• Have provided signed written informed consent

You may not qualify if:

• Age \< 35 years
• Patients requiring , emergency or salvage cardiac surgical operation
• Participation in another clinical study or treatment with another investigational product 30 days prior to randomization
• Moribund patient not expected to survive surgery 12 months after surgery
• Active malignant disease with a short life expectancy, not eligible for surgery
• Hemoglobin levels \> 155 g/dL for women and \>167 g/dl for men (upper reference limits for TYKSlab)
• Ferritin levels \>150 ug/l for women and \>400 ug/l for men.
• Renal dialysis therapy for chronic renal failure or severe preoperative renal impairment (eGFR\<30ml/min).
• Study treatment can't be infused during the required time window: minimum 48 hours and maximum 21 days before the operation.
• Ongoing oral or parenteral iron medication at the time of randomization
• Iron or haemoglobin metabolism or synthesis disorders
• Primary or secondary hemochromatosis (in males and postmenopausal females, a serum ferritin value of over 300 ng/mL (670 pmol/L); and in premenopausal females, a serum ferritin value of over 150\[17\] or 200\[18\] ng/mL (330 or 440 pmol/L) indicates iron overload).
• Porphyria cutanea tarda.
• Liver failure (Child-Pugh class B or C).
• Pregnancy.

Sponsors & Collaborators

• Turku University Hospital: lead
• Vifor Pharma: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Postoperative Complications; Aortic Valve Stenosis; Aortic Aneurysm, Thoracic

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Aneurysm; Aneurysm; Aortic Diseases

Central Study Contacts

Jarmo M Gunn, adj. professor

CONTACT

+35823130000; jarmo.gunn@tyks.fi

Tuija Vasankari, RN

CONTACT

+35823130000

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinding, study drug administration by separate staff blinded from participant and investigators
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled 1:1

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 29, 2018
• Study Start: October 2, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)