Patient Blood Management in Patients Scheduled for Cardiac Surgery

Recruiting

• Conditions: Anemia; Anemia, Iron-Deficiency; Iron Deficiency Anemia Treatment; Iron Deficiency Anemia (IDA); Cardiac Surgical Patients; Blood Loss, Surgical
• Interventions: Drug: Iron

• Registration Number: NCT06637137
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The ICARUS 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective cardiac surgery in order to correct any states of hypoferritinemia (low iron in the blood) to promote recovery from blood losses related to cardiac surgery. This objective is strongly encouraged by the good use of blood programs currently in force at our foundation.

In particular, the research presented here intends to demonstrate a reduction in the number of intra- and post-operative transfusions.

Detailed Description

A significant percentage of patients schduled for cardiac surgery have an absolute or relative iron deficiency (ID) with or without anemia. Preoperative outpatient treatment of anemia and iron deficiency is one of the pillars of patient blood management (PBM). Data collected at our institution show that 35% of patients undergoing cardiac surgery at the Foundation receive 2 or more units of concentrated red blood cells at surgery or in the following 7 days. A recently published ambispective study (ICARUS) demonstrated that intravenous iron supplementation, even in the immediate pre-operative period (i.e 1 or 2 days), reduces the number of post-operative transfusions and the length of hospital stay. Similar results were recently obtained by other authors in a randomized study. Assuming the correction of ID at an earlier stage, the haematological outcome could be significantly better, with a reduction in the percentage of patients transfused and in the average transfusion requirement, increase in haemoglobin levels at discharge, improvement in clinical conditions and possible further reduction of the length of stay. All this could translate into a further reduction in costs related to the intervention.

The study is observational and involves the early application of the PBM program based on good clinical practice which includes the correction of absolute or relative ID. This deficiency will be treated at least 2 weeks before the planned cardiac surgery: the patient will receive an i.v. of iron in the clinic, in accordance with the indications, doses and route of administration for which the use of the drug is approved and the drug distributed on the market. At the same time as iron administration, vitamin supplementation will be prescribed (Vitamin B12 1 mg total subcutaneously) and oral folic acid (5 mg/day).

Study Timeline

• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Status Verified: 2025-02
• Study Start: 2025-02-24
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

• all adult patients scheduled for elective cardiac surgery

Exclusion Criteria

• pregnancy
• dyalisis
• patient's refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospectic cohort	Iron	patients scheduled for cardiac surgery who fulfil the inclusion criteria

Primary Outcome Measures

Name	Time	Method
Percentage of patients receiving RBC transfusion within post-operative day 7	within post operative day 7	number of RBC units transfused from the operating room till post operative day 7

Secondary Outcome Measures

Name	Time	Method
cost measured in euros for the IDA treatment and blood product consumption	from enrollment to 1 week after surgery	We will assess if ID screening and iron replacement is cost-effective, considering the costs, expressed in euros, of the treatment with ferric carboxymaltose, folic acid and B12 vitamin, the pRBC consumption and hospitalization (either in ICU or in the regular ward).
Hb values at last postoperative control within 7 days from surgery	within post operative day 7	Hb values at last postoperative control within 7 days from surgery
ICU lenght of stay	through study completion, an average of 2 year	lenght of stay in ICU
Number of allogenic blood products administered	within the first 7 days post operative	Number of allogenic blood products administered (i.e fresh frozen plasma or platelet units).
mortality	from surgery within post operative day 7	patients died within the first 7 days after surgery
Hospital Lenght of Stay	through study completion, an average of 2 year	The number of days spent in the hospital

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Roma, Italy