ProPBM : A Modified Patient Blood Management Protocol

ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery

The introduction of a modified perioperative patient blood management protocol with intravenous iron intervention for iron deficiency anaemic patients would reduce the need for allogenic blood transfusion and reduce perioperative morbidity and mortality.

Patient blood management (PBM), refers to "the timely application of evidence based medical and surgical concepts designed to maintain haemoglobin concentration, optimise haemostasis and minimize blood loss in an effort to improve patient outcome.

PBM relies on three corresponding aspects:

1. Optimising haemopoiesis,
2. Minimising bleeding and blood loss
3. Harnessing and optimising physiological tolerance of anaemia.

Therefore, this randomised control trial aims to study the effect of applying a modified patient blood management protocol on the perioperative allogenic blood transfusion incidence, mortality and morbidity in patients undergoing major surgery in gynaecology, intraabdominal surgery and orthopaedics comparing with current practice.

Inclusion Criteria:

• Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics
• Major surgery defined as either Intrabdominal surgery or main joint surgery, Risk of blood loss >15% blood volume
• Aged between 18 to 80 years of age
• The patient must be willing and able to provide written informed consent for the study

Exclusion Criteria:

• Allergy or known sensitivity to parenteral iron
• Hypersensitivity to the active substance, Iron(III) Isomaltoside or any of its excipients listed in the summary of product characteristics
• Patients with iron overload