NCT03574311

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

A Phase IV Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective or Urgent Cardiac Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose	A single dose of drug or placebo is administered preoperatively to participants
OTHER	Physiological saline	Single infusion 100 ml physiological saline infusion preoperatively

Timeline

• Start date: 2018-10-02
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2018-06-29
• Last updated: 2021-04-20

Locations

1 site across 1 country: Finland