Hepcidin and Iron Storage Sub-Study: The relationship of hepcidin to patient outcomes after cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12621000952842

Enrollment

300

Registered

2021-07-21

Start date

2022-08-05

Completion date

2026-06-24

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project will be part of a larger international effort that is examining the best way to transfuse patients who are 65 years old or younger and undergoing cardiac surgery, We will determine if there is an association between baseline hepcidin values and patient outcomes 28 days after cardiac surgery, after taking into account iron storage, haemoglobin values, transfusion strategy and other factors known to influence cardiac surgical outcomes, which has not been examined previously. We will also explore the association between hepcidin and the recovery of haemoglobin levels back to normal 30 days post-surgery after accounting for other factors that may cause haemoglobin to recover slowly.

Interventions

Patients will be consented for the collection of additional blood tests at -7 to 0 days to index surgery and blood tests at 30 days after cardiac surgery. All Australian participants enrolled in NCT04754022, a randomised controlled trial comparing two commonly used transfusion strategies in those undergoing cardiac surgery, will be co-recruited to this sub-study. The exposure of interest are those receiving the restrictive transfusion strategy as part of the study registered in NCT04754022.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Australian participants of the NCT04754022 study 2. Age 18 to 65 years of age 3. Planned cardiac surgery using cardiopulmonary bypass 4. Informed consent obtained 5. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion criteria

1. Patients who are unable to receive or who refuse blood products 3. Patients who are involved in a preoperative autologous pre-donation program 4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device 5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

Outcome results