Clinical trial NCT03560687: CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery
Official title: CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
Heart Surgery
Iron Supplementation
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 1023
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of 1000 consecutive patients undergoing heart surgery to either Iron supplementation or Control
Primary purpose: TREATMENT

Brief 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 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

Eligibility criteria: Inclusion Criteria:

Undergoing elective Heart Surgery -

Exclusion Criteria:

- Emergent or Urgent Indication

Primary outcomes:
measure: Preoperative Hemoglobin Level
timeFrame: 30 days from enrollment
Secondary outcomes:
measure: Compliance to drug
timeFrame: 30 days from enerollemnt
measure: Cost-effectiveness in terms of cost of drug vs saved blood units
timeFrame: 30 days after operation
measure: Hemoglobin Level 24 hours after operation
timeFrame: 24 hours after index operation
measure: Hemoglobin Level 48 hours after operation
timeFrame: 48 hours after index operation
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Cardiochirurgia European Hospital
Study officials:
affiliation: European Hospital
name: Luca Weltert
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.