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Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery

NCT03759964 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2021-10-11

No results posted yet for this study

Summary

Several studies using new forms of intravenous iron showed that it is effective in treating perioperative anemia in orthopedic and digestive surgery. Effects of ferric carboxymaltose have not been assessed in the settings of cardiac surgery.

This study will compare ferric carboxymaltose to placebo in a randomized trial design where ferric carboxymaltose / placebo will be administered in the postoperative period (Day 1) after cardiac surgery. A total sample size of 200 patients (100 per group) will be needed.

The FCAACS trial will assess the impact of administering intravenous iron (Ferric carboxymaltose) after cardiac surgery with cardiopulmonary bypass (CPB) on the:

* incidence of postoperative anemia
* incidence of postoperative transfusion
* incidence of complications related to intravenous iron

All the surgeries will be performed by the same surgical team and follow-up will be ensured by the same Cardiac Surgery Unit (CSU) team according to department's standard protocols.

Participants in the Ferric carboxymaltose group will receive 1g of Ferric carboxymaltose diluted in 100 mL of IV isotonic serum saline, whereas participants in the Placebo group will receive 100 mL of IV Placebo

Conditions

  • Anemia, Iron Deficiency

Interventions

DRUG

Ferric carboxymaltose

1g of Ferric carboxymaltose diluted in 100 mL of IV isotonic serum saline at day 1 following surgery

DRUG

Placebo

100 mL of IV isotonic serum saline at day 1 following surgery

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY

  • Saint-Joseph University

    collaborator OTHER

  • St Joseph University, Beirut, Lebanon

    lead OTHER

Principal Investigators

  • Samia Madi-Jebara, Pr · St Joseph University Beirut

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2020-12-09
Completion
2021-01-02

Countries

  • Lebanon

Study Locations

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Entities

Drugs

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 NCT03759964 on ClinicalTrials.gov