Mechanistic Observational Study of Anaemia and Inflammation in patients undergoing Cardiac Surgery

Not Applicable

• Conditions: Anaemia; Cardiovascular disease; Recovery from surgery; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery; Blood - Anaemia; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12623001060639
• Lead Sponsor: Department of Critical Care, The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-04
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All patients undergoing coronary artery bypass or cardiac valve surgery

Exclusion Criteria

Undergoing cardiac surgery that is not CABG and/or cardiac valve procedures (i.e., ascending aorta or root replacement, solid organ transplantation, etc.)
End-stage renal failure requiring dialysis
Active solid organ malignancy
Taking antibiotic therapy for active infection at time of operation
Acquired/clonal haematological malignancies (including leukaemia, lymphoma, myeloma, myelodysplasia, or aplastic anaemia)
Haemoglobinopathy (including a-globin and/or ß-globin gene mutations [thalassaemia] and sickle cell trait)
Inherited red cell membrane disorders (including glucose-6-phosphate-dehydrogenase and pyruvate kinase deficiency)
Active haemolytic processes (mechanical or autoimmune)
Preoperative requirement for erythropoiesis stimulating agents
Age < 18 years
Pregnancy or breastfeeding
Surgical plan requiring off-pump technique
Preoperative Hb < 130 g/L if male and < 120 g/L if female
Preoperative C-reactive protein (CRP) concentration > 5 mg/L
Emergency surgery (i.e., following decision to operate, the patient proceeds to surgery before the next business day)
Not willing to attend for blood tests following discharge.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the rate of change in haemoglobin concentration in g/L. This will be assessed using a blood test.[ Measured at multiple timepoints: postoperative day (POD) 1, POD 2, POD 4, POD 8, POD 14, POD 30 and POD 64]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be the rate of change in serum hepcidin (ng/L). This will be assessed using a blood test. [ Measured at multiple timepoints: postoperative day (POD) 1, POD 2, POD 4, POD 8, POD 14, POD 30 and POD 64]