Anemia, Iron DeficiencyPhase 4FCAACSNCT03759964
Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery
A Phase 4 study testing Ferric carboxymaltose in people with Anemia, Iron Deficiency, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- Ferric carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Dec 2018to 2 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients < 18 years
- Urgent surgery
- Off-pump cardiac surgery
- Redo cardiac surgery
- Preoperative anemia (Hb < 10g/l or Ht < 30%)
- Transfusion within 72h preoperatively
Show all 12Show fewer
- Pregnancy
- History of asthma or other specific allergies
- History of allergy to iron
- Acute infection
- Hepatic insufficiency
- Renal insufficiency (creatinine Clearance < 30ml/min)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ferric Carboxymaltose (Ferinject®) Administered After Cardiac Surgery: (FCAACS) Effects On Correction Of Anemia And Transfusion Rates: A Prospective Randomized Controlled Trial
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.
Read more
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
Read the 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.
- Conditions
- Anemia, Iron Deficiency
- Being tested
- Ferric carboxymaltose, Placebo
- Keywords
- cardiac surgery, ferric carboxymaltose, anemia, transfusion
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject®
1g of Ferric carboxymaltose diluted in 100 mL of IV isotonic serum saline at day 1 following surgery
PlaceboDrug
Also called Serum saline
100 mL of IV isotonic serum saline at day 1 following surgery
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose group | Active comparator | Ferric carboxymaltose group will receive 1g of Ferric carboxymaltose at day 1 following cardiac surgery Receives: Drug: Ferric carboxymaltose |
| Placebo group | Placebo comparator | Placebo group will receive 100 mL of IV isotonic serum saline at day 1 following cardiac surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of hemoglobin (g/dL) from preoperative until day 30 after surgery
mean ± standard deviation, measured at 5 timepoints
Measured: 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)
mean ± standard deviation, measured at 5 timepoints
Measured: 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)
measured at 4 timepoints
Measured: 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)
measured at 4 timepoints
Measured: 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)
measured at 4 timepoints
Measured: Preoperative (Day -2), Day 1 [CSU, before study drug], Day 5 [hospital discharge], Day 30
Number of red cell packs transfused (final value)
mean ± standard deviation, measured at 3 timepoints
Measured: Day 1, Day 5,and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start15 Dec 2018
- Primary completion9 Dec 2020
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma, Saint-Joseph University
- Responsible party
- Principal investigator, Samia Madi Jebara, St Joseph University, Beirut, Lebanon
- Investigators
- Samia Madi-Jebara, Pr, Principal investigator, St Joseph University Beirut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759964
- Sponsor's protocol ID
- CEHDF 1050
- Acronym
- FCAACS
- Status last verified
- Oct 2021
- First submitted
- 25 Nov 2018
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36375780
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ferric Carboxymaltose (Ferinject®) Administered After Cardiac Surgery: (FCAACS) Effects On Correction Of Anemia And Transfusion Rates: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03759964
- Acronym / sponsor ID
- FCAACS / CEHDF 1050
- Conditions
- Anemia, Iron Deficiency
- Keywords
- cardiac surgery, ferric carboxymaltose, anemia, transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Collaborators
- Vifor Pharma, Saint-Joseph University
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ferric Carboxymaltose group | Active comparator | Drug: Ferric carboxymaltoseFerric carboxymaltose group will receive 1g of Ferric carboxymaltose at day 1 following cardiac surgery |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo group will receive 100 mL of IV isotonic serum saline at day 1 following cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- Patients < 18 years
- Urgent surgery
- Off-pump cardiac surgery
- Redo cardiac surgery
- Preoperative anemia (Hb < 10g/l or Ht < 30%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltoseAlso: Ferinject®1g of Ferric carboxymaltose diluted in 100 mL of IV isotonic serum saline at day 1 following surgery | Drug | Ferric Carboxymaltose group |
| PlaceboAlso: Serum saline100 mL of IV isotonic serum saline at day 1 following surgery | Drug | Placebo group |
Primary outcome
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
5 secondary outcomes
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
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
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
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
Number of red cell packs transfused (final value)
Time frame: Day 1, Day 5,and Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 36375780Houry 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samia Madi-Jebara, Pr principal investigator
St Joseph University Beirut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric carboxymaltose in people with Anemia, Iron Deficiency, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03759964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.