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Trial record 34 of 380 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT03759964
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
Vifor Pharma
Saint-Joseph University
Information provided by (Responsible Party):
Samia Madi Jebara, St Joseph University, Beirut, Lebanon

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


Condition or disease Intervention/treatment Phase
Anemia, Iron Deficiency Drug: Ferric carboxymaltose Drug: Placebo Phase 4

Detailed Description:

Anemia is very common in the perioperative of major surgery affecting about 30% of patients preoperatively and more than 80% postoperatively. Anemia is an independent risk factor of morbi-mortality.

Iron deficiency is the first cause of anemia. Physiological reserves of iron are not important, and the correction of anemia after hemorrhage is very slow. Hence, it takes 90 days to return to 80% of the basic Hb level after a blood donation of 500ml, and more than 150 days (almost 6 months), if one is deficient in iron. This is why iron is used to correct anemia that occurs after bleeding. There are two routes for iron administration: oral and intravenous.

Gastrointestinal absorption of iron is limited to 10-15 mg/d even when ingested doses are increased. This absorption is decreased in the presence of an inflammatory state, which is very common in the postoperative period.

The intravenous route allows the delivery of significantly higher doses of iron (up to 1000 mg in 1 infusion), without any limitation related to absorption. This is why it is interesting to administer it perioperatively where the expected delays are short.

There are currently new intravenous iron formulations that have two advantages: a shorter intravenous injection time and a higher maximum injectable dose per infusion. These new forms are risk-free, with no serious allergy described so far in the literature.

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.

To assess the impact of ferric carboxymaltose in cardiac surgery, it will be compared to placebo in a randomized trial design, where ferric carboxymaltose / placebo will be administered in the postoperative period. Ferric carboxymaltose / placebo will be an add-on to the current treatment of patients in the postoperative period of cardiac surgery, the group that will be receiving placebo reflects the current management of the patients in these settings.

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

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. A total sample size of 200 patients (100 per group) will be needed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ferric Carboxymaltose (Ferinject®) Administered After Cardiac Surgery: (FCAACS) Effects On Correction Of Anemia And Transfusion Rates: A Prospective Randomized Controlled Trial
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ferric Carboxymaltose group
Ferric carboxymaltose group will receive 1g of Ferric carboxymaltose at day 1 following cardiac surgery
Drug: Ferric carboxymaltose
1g of Ferric carboxymaltose diluted in 100 mL of IV isotonic serum saline at day 1 following surgery
Other Name: Ferinject®

Placebo Comparator: Placebo group
Placebo group will receive 100 mL of IV isotonic serum saline at day 1 following cardiac surgery
Drug: Placebo
100 mL of IV isotonic serum saline at day 1 following surgery
Other Name: Serum saline




Primary Outcome Measures :
  1. Change in level of hemoglobin (g/dL) from preoperative until day 30 after surgery [ Time Frame: Preoperative (Day -2), Day 0 [CSU admission], Day 2 [CSU discharge], Day 5 [hospital discharge], Day 30 ]
    mean ± standard deviation, measured at 5 timepoints


Secondary Outcome Measures :
  1. change in Hematocrit from preoperative until day 30 after surgery (final value) [ Time Frame: Preoperative (Day -2), Day 0 [CSU admission], Day 2 [CSU discharge], Day 5 [hospital discharge], Day 30 ]
    mean ± standard deviation, measured at 5 timepoints

  2. Change in Reticulocytes count from preoperative until day 30 after surgery (final value) [ Time Frame: Preoperative (Day -2), Day 2 [CSU discharge], Day 5 [hospital discharge], Day 30 ]
    measured at 4 timepoints

  3. Change in Percentage of transferrin from preoperative until day 30 after surgery (final value) [ Time Frame: Preoperative (Day -2), Day 1 [CSU, before study drug], Day 5 [hospital discharge], Day 30 ]
    measured at 4 timepoints

  4. Change in Ferritin from preoperative until day 30 after surgery (final value) [ Time Frame: Preoperative (Day -2), Day 1 [CSU, before study drug], Day 5 [hospital discharge], Day 30 ]
    measured at 4 timepoints

  5. Number of red cell packs transfused (final value) [ Time Frame: Day 1, Day 5,and Day 30 ]
    mean ± standard deviation, measured at 3 timepoints


Other Outcome Measures:
  1. Total bleeding (mL) until drain removal (final value) [ Time Frame: From Day 0 until Day 2 ]
    mean ± standard deviation

  2. Time to tracheal tube removal, measured in hours (final value) [ Time Frame: From Hour 0 until Hour 6 (on average, until tracheal tube removal) ]
    mean ± standard deviation

  3. Length of stay in the CSU measured in Days [ Time Frame: From Day 0 [CSU admission] until Day 2 [on overage, CSU discharge] ]
    median and interquartile range

  4. Surgical exploration for bleeding (Boolean, proportion) [ Time Frame: From Day 0 [CSU admission] until Day 2 [on overage, CSU discharge] ]
    Proportion, with 95% confidence interval

  5. Complications related to administration of Ferric carboxymaltose (proportion) [ Time Frame: From Day 0 until Day 30 ]
    Proportion, with 95% confidence interval



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients admitted for elective cardiac surgery under cardiopulmonary bypass, with no exclusion criteria, and having signed an informed consent, will be enrolled in the study.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759964


Contacts
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Contact: Samia Madi-Jebara, Pr +9611604000 ext 8939 samia.jebara@gmail.com

Locations
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Lebanon
Hotel Dieu de France Hospital Recruiting
Beirut, Lebanon, 166830
Contact: Samia N Madi-Jebara, MD    009611604000 ext 8939    samiajebara@gmail.com   
Contact: Ghassan N Sleilaty, MD    009611604000 ext 7428    ghassan.sleilaty@usj.edu.lb   
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon
Vifor Pharma
Saint-Joseph University
Investigators
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Principal Investigator: Samia Madi-Jebara, Pr St Joseph University Beirut

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Responsible Party: Samia Madi Jebara, Professor, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier: NCT03759964     History of Changes
Other Study ID Numbers: CEHDF 1050
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samia Madi Jebara, St Joseph University, Beirut, Lebanon:
cardiac surgery
ferric carboxymaltose
anemia
transfusion
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics