AnemiaCHSNCT03560687
CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery
A study testing Sucrosomial Iron in people with Anemia, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial summary
This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia
- What is being tested?
- Sucrosomial Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,023 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2018to 9 Jul 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing elective Heart Surgery -
Who cannot join
- Emergent or Urgent Indication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation
This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.
Read the detailed description
This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.
Secondary Objectives are
- Changes in blood chemistry and biochemical tests between pre- and post-intervention
- Evaluation of tolerability and compliance of supplementation with Sucrosomal Iron
- Reduction in the number of transfusions and blood bags used
- Evaluation of cost-effectiveness
- Conditions
- Anemia
- Being tested
- Sucrosomial Iron
- Keywords
- Anemia, Heart Surgery, Iron Supplementation
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrosomial IronDrug
Also called CardioSideral
CardioSideral 2 caps per day
| Study group | Role | What they receive |
|---|---|---|
| CardioSIDERAL | Experimental | Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation Receives: Drug: Sucrosomial Iron |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Hemoglobin Level
Preoperative Hemoglobin Level
Measured: 30 days from enrollment
Secondary outcomes (4)
Compliance to drug
Discontinuation rate due to adverse effects
Measured: 30 days from enerollemnt
Cost-effectiveness in terms of cost of drug vs saved blood units
Cost-effectiveness in terms of cost of drug vs saved blood units
Measured: 30 days after operation
Hemoglobin Level 24 hours after operation
Hemoglobin Level 24 hours after operation
Measured: 24 hours after index operation
Hemoglobin Level 48 hours after operation
Hemoglobin Level 48 hours after operation
Measured: 48 hours after index operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start15 Oct 2018
- Primary completion1 May 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of 1000 consecutive patients undergoing heart surgery to either Iron supplementation or Control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Weltert, Cardiochirurgia E.H.
- Investigators
- Luca Weltert, Principal investigator, European Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560687
- Sponsor's protocol ID
- 2018-1
- Acronym
- CHS
- Status last verified
- Jul 2020
- First submitted
- 7 Jun 2018
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L. Benefits of pre-operative oral Sucrosomial(R) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender. Blood Transfus. 2023 Jul;21(4):305-313. doi: 10.2450/2022.0222-22. Epub 2022 Nov 25.
PubMed 36580029Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512.
PubMed 34710946
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation
- ClinicalTrials.gov ID
- NCT03560687
- Acronym / sponsor ID
- CHS / 2018-1
- Conditions
- Anemia
- Keywords
- Anemia, Heart Surgery, Iron Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 18 Jun 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.
This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.
Detailed description
This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.
Secondary Objectives are
- Changes in blood chemistry and biochemical tests between pre- and post-intervention
- Evaluation of tolerability and compliance of supplementation with Sucrosomal Iron
- Reduction in the number of transfusions and blood bags used
- Evaluation of cost-effectiveness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization of 1000 consecutive patients undergoing heart surgery to either Iron supplementation or Control
| Arm | Type | Receives |
|---|---|---|
| CardioSIDERAL | Experimental | Drug: Sucrosomial IronAdminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing elective Heart Surgery -
Key exclusion criteria (1 listed)
- Emergent or Urgent Indication
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 |
|---|---|---|
| Sucrosomial IronAlso: CardioSideralCardioSideral 2 caps per day | Drug | CardioSIDERAL |
Primary outcome
Preoperative Hemoglobin Level
Time frame: 30 days from enrollment
Preoperative Hemoglobin Level
4 secondary outcomes
Compliance to drug
Time frame: 30 days from enerollemnt
Cost-effectiveness in terms of cost of drug vs saved blood units
Time frame: 30 days after operation
Hemoglobin Level 24 hours after operation
Time frame: 24 hours after index operation
Hemoglobin Level 48 hours after operation
Time frame: 48 hours after index operation
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 13 Jul 2020.
- Derived from this study: PubMed 36580029Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L. Benefits of pre-operative oral Sucrosomial(R) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender. Blood Transfus. 2023 Jul;21(4):305-313. doi: 10.2450/2022.0222-22. Epub 2022 Nov 25.
- Derived from this study: PubMed 34710946Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512.
- Individual participant dataSharing planned: No
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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.
Luca Weltert principal investigator
European Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrosomial Iron in people with Anemia, run by Cardiochirurgia E.H. at 1 site in Italy.
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 1 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 13 Jul 2020. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Preoperative Hemoglobin Level (time frame: 30 days from enrollment). 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 NCT03560687, which also lists 2 linked publications.
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 13 Jul 2020.