Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CardioSIDERAL | Experimental | Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrosomial Iron | Drug | CardioSideral 2 caps per day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Hemoglobin Level | Preoperative Hemoglobin Level | 30 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to drug | Discontinuation rate due to adverse effects | 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 |
Not provided
Inclusion Criteria:
Undergoing elective Heart Surgery -
Exclusion Criteria:
- Emergent or Urgent Indication
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luca Weltert | European Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiochirurgia European Hospital | Rome | 00152 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36580029 | Derived | 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. | |
| 34710946 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718012 | sucrosomial iron |
Not provided
Not provided
Not provided
Randomization of 1000 consecutive patients undergoing heart surgery to either Iron supplementation or Control
Not provided
Not provided
Single blinded
| 30 days after operation |
| Hemoglobin Level 24 hours after operation | Hemoglobin Level 24 hours after operation | 24 hours after index operation |
| Hemoglobin Level 48 hours after operation | Hemoglobin Level 48 hours after operation | 48 hours after index operation |
| Pierelli 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. |