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

NCT03759964 | Completed Phase 4

• 1 other identifier: CEHDF 1050
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiac surgery; ferric carboxymaltose; anemia; transfusion

Outcome Measures

Primary Outcomes (1)

• Change in level of hemoglobin (g/dL) from preoperative until day 30 after surgery

  mean ± standard deviation, measured at 5 timepoints

  Preoperative (Day -2), Day 0 [CSU admission], Day 2 [CSU discharge], Day 5 [hospital discharge], Day 30

Secondary Outcomes (5)

• change in Hematocrit from preoperative until day 30 after surgery (final value)

  Preoperative (Day -2), Day 0 [CSU admission], Day 2 [CSU discharge], Day 5 [hospital discharge], Day 30

• Change in Reticulocytes count from preoperative until day 30 after surgery (final value)

  Preoperative (Day -2), Day 2 [CSU discharge], Day 5 [hospital discharge], Day 30

• Change in Percentage of transferrin from preoperative until day 30 after surgery (final value)

  Preoperative (Day -2), Day 1 [CSU, before study drug], Day 5 [hospital discharge], Day 30

• Change in Ferritin from preoperative until day 30 after surgery (final value)

  Preoperative (Day -2), Day 1 [CSU, before study drug], Day 5 [hospital discharge], Day 30

• Number of red cell packs transfused (final value)

  Day 1, Day 5,and Day 30

Other Outcomes (5)

• Total bleeding (mL) until drain removal (final value)

  From Day 0 until Day 2

• Time to tracheal tube removal, measured in hours (final value)

  From Hour 0 until Hour 6 (on average, until tracheal tube removal)

• Length of stay in the CSU measured in Days

  From Day 0 [CSU admission] until Day 2 [on overage, CSU discharge]

Study Arms (2)

Ferric Carboxymaltose group

ACTIVE COMPARATOR

Ferric carboxymaltose group will receive 1g of Ferric carboxymaltose at day 1 following cardiac surgery

Drug: Ferric carboxymaltose

Placebo group

PLACEBO COMPARATOR

Placebo group will receive 100 mL of IV isotonic serum saline at day 1 following cardiac surgery

Drug: Placebo

Interventions

Ferric carboxymaltose DRUG

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

Also known as: Ferinject®

Ferric Carboxymaltose group

Placebo DRUG

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

Also known as: Serum saline

Placebo group

Eligibility Criteria

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

You may not qualify if:

• Patients \< 18 years
• Urgent surgery
• Off-pump cardiac surgery
• Redo cardiac surgery
• Preoperative anemia (Hb \< 10g/l or Ht \< 30%)
• Transfusion within 72h preoperatively
• Pregnancy
• History of asthma or other specific allergies
• History of allergy to iron
• Acute infection
• Hepatic insufficiency
• Renal insufficiency (creatinine Clearance \< 30ml/min)

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead
• Vifor Pharma: collaborator
• Saint-Joseph University: collaborator

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, 166830, Lebanon

Location

Related Publications (1)

• Houry M, Tohme J, Sleilaty G, Jabbour K, Bou Gebrael W, Jebara V, Madi-Jebara S. Effects of ferric carboxymaltose on hemoglobin level after cardiac surgery: A randomized controlled trial. Anaesth Crit Care Pain Med. 2023 Feb;42(1):101171. doi: 10.1016/j.accpm.2022.101171. Epub 2022 Nov 11.

  PMID: 36375780 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Samia Madi-Jebara, Pr

  St Joseph University Beirut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: FCAACS will be a parallel group randomized trial, with a 2-group design and no crossover. Allocation ratio will be 1/1, in an equivalence framework.

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 30, 2018
• Study Start: December 15, 2018
• Primary Completion: December 9, 2020
• Study Completion: January 2, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

LE (1)