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

NCT03574311 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2021-04-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY

  • Turku University Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574311 on ClinicalTrials.gov