AnemiaPhase 4NCT02939794
The Effect of Ferric Carboxymaltose on Hemoglobin and Blood Transfusion in Cardiac Surgery
A Phase 4 study testing Ferinject in people with Anemia, run by Rambam Health Care Campus.
Trial summary
Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion) and more than 80% of the patients receives at least one unit of red blood cell transfusion. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anemia
- What is being tested?
- Ferinject
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Aug 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Patient candidates for open heart surgery (coronary artery bypass, valve replacement, or a combination of both).
- Hemoglobin above 12g/dL in women and above than 13g\dL in men.
Who cannot join
- Patients who require emergency heart surgery.
- Patients who are not hemodynamically stable or intubated pre-operatively.
- Patients with a known sensitivity to iron.
- Patients with a known history of allergies (rashes, etc.).
- Patients with liver failure (alanine aminotransferase> 3 times normal).
- Patients with cirrhosis.
Show all 14Show fewer
- Patients with an active infection.
- Patients with rheumatoid arthritis and indications of an active infection.
- Pregnant women.
- Lactating women.
- Patients with anemia prior to surgery for any reason (B12 deficiency or folic acid deficiency).
- Patients participating in another drug trial.
- Patients treated with iron who took medication within the four weeks prior to surgery.
- Patients who received a blood transfusion in the four weeks prior to surgery.
About this study
Official title: The Effect of Intra Venus Ferric Carboxymaltose Preoperative on Hemoglobin and Blood Transfusion Post Cardiac Surgery
Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion) and more than 80% of the patients receives at least one unit of red blood cell transfusion.
There were number of attempts to prevent the postoperative anemia by giving erythropoietin, Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after the cardiac surgery.
Read the detailed description
Research Objectives
The study objectives are:
- Determine hemoglobin values in non-anemic patients given ferric Carboxymaltose prior to and post heart surgery.
- Determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation.
Research Methods Prospective, randomized, double-blind, placebo-controlled research. All patients who are in the cardiac surgery department for bypass surgery, valve replacement surgery or combined surgery will be eligible to participate in the study. The study will be presented and explained to all patients and, if they consent, patients will be divided into two random groups. One group will receive Ferinject IV 24-48 hours prior to surgery. The second group will receive a placebo drug in the same time period as when the drug Ferinject is administered.
The Population Studied All patients aged 18 or older hospitalized at the Rambam Medical Center and are candidates for open-heart surgery (coronary artery bypass, valve, combined).
- Conditions
- Anemia
- Being tested
- Ferinject, Placebo
- Keywords
- cardiac surgery, hemoglobin, iron
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
Also called ferric carboxymaltose
1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
PlaceboDrug
Also called Saline
Saline (normal saline, sodium chloride)
| Study group | Role | What they receive |
|---|---|---|
| ferinject | Active comparator | -Patients will receive 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery Receives: Drug: Ferinject |
| placebo | Placebo comparator | Patients will receive a placebo drug intravenous approximately 24 hours before surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
In order to determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation, we will count the number of red packed cells and hemoglobin will be measured in gr\dl%
- All patients post heart surgery will be admitted to the intensive care unit cardiac surgery for a minimum of 48 hours. The unit has regular and routine monitoring for blood tests (blood chemistry panel, coagulation) and blood gases.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
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 AnemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Carmel Medical Center, The Baruch Padeh Medical Center, Poriya
- Responsible party
- Principal investigator, Gil Bolotin MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939794
- Sponsor's protocol ID
- 105-02
- Status last verified
- Oct 2016
- First submitted
- 31 May 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Friedman T, Dann EJ, Bitton-Worms K, Makhoul M, Glam R, Weis A, Tam DY, Bolotin G. Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia. Br J Anaesth. 2023 Dec;131(6):981-988. doi: 10.1016/j.bja.2023.09.007. Epub 2023 Oct 12.
PubMed 37838604
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra Venus Ferric Carboxymaltose Preoperative on Hemoglobin and Blood Transfusion Post Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02939794
- Acronym / sponsor ID
- 105-02
- Conditions
- Anemia
- Keywords
- cardiac surgery, hemoglobin, iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Carmel Medical Center, The Baruch Padeh Medical Center, Poriya
- Study start
- Nov 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- 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.
Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion) and more than 80% of the patients receives at least one unit of red blood cell transfusion.
There were number of attempts to prevent the postoperative anemia by giving erythropoietin, Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after the cardiac surgery.
Detailed description
Research Objectives
The study objectives are:
- Determine hemoglobin values in non-anemic patients given ferric Carboxymaltose prior to and post heart surgery.
- Determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation.
Research Methods Prospective, randomized, double-blind, placebo-controlled research. All patients who are in the cardiac surgery department for bypass surgery, valve replacement surgery or combined surgery will be eligible to participate in the study. The study will be presented and explained to all patients and, if they consent, patients will be divided into two random groups. One group will receive Ferinject IV 24-48 hours prior to surgery. The second group will receive a placebo drug in the same time period as when the drug Ferinject is administered.
The Population Studied All patients aged 18 or older hospitalized at the Rambam Medical Center and are candidates for open-heart surgery (coronary artery bypass, valve, combined).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ferinject | Active comparator | Drug: Ferinject-Patients will receive 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery |
| placebo | Placebo comparator | Drug: PlaceboPatients will receive a placebo drug intravenous approximately 24 hours before surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- Patient candidates for open heart surgery (coronary artery bypass, valve replacement, or a combination of both).
- Hemoglobin above 12g/dL in women and above than 13g\dL in men.
Key exclusion criteria (14 listed)
- Patients who require emergency heart surgery.
- Patients who are not hemodynamically stable or intubated pre-operatively.
- Patients with a known sensitivity to iron.
- Patients with a known history of allergies (rashes, etc.).
- Patients with liver failure (alanine aminotransferase> 3 times normal).
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 |
|---|---|---|
| FerinjectAlso: ferric carboxymaltose1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery | Drug | ferinject |
| PlaceboAlso: SalineSaline (normal saline, sodium chloride) | Drug | placebo |
Primary outcome
In order to determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation, we will count the number of red packed cells and hemoglobin will be measured in gr\dl%
Time frame: 2 years
• All patients post heart surgery will be admitted to the intensive care unit cardiac surgery for a minimum of 48 hours. The unit has regular and routine monitoring for blood tests (blood chemistry panel, coagulation) and blood gases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Derived from this study: PubMed 37838604Friedman T, Dann EJ, Bitton-Worms K, Makhoul M, Glam R, Weis A, Tam DY, Bolotin G. Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia. Br J Anaesth. 2023 Dec;131(6):981-988. doi: 10.1016/j.bja.2023.09.007. Epub 2023 Oct 12.
- Individual participant dataSharing planned: Yes
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject in people with Anemia, run by Rambam Health Care Campus.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
In order to determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation, we will count the number of red packed cells and hemoglobin will be measured in gr\dl% (time frame: 2 years). 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 NCT02939794, 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 28 Oct 2016.