Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637137
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
Patient Blood Management in Patients Scheduled for Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient Blood Management in Cardiac Surgical Patients the ICARUS-2 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICARUS-2
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
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 ie 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 iv 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 mgday
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 iv 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 mgday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None