Patient Blood Management – A new standard of care

Each year, over one million cardiac surgical procedures take place around the world. Like other major surgeries, a significant number of cardiac surgeries require the transfusion of blood components such as plasma, red blood cells and platelet concentrates – something which, by itself, is not without significant risk to patients.

“Although transfusion can be life-saving in many critical situations,” says Professor Thorsten Haas, Head of the Patient Blood Management (PBM) programme at the Children’s Hospital in Zürich, “It also carries inherent risks, such as infections, respiratory complications and immunomodulation, which can increase patient morbidity and mortality.”

Approaches to reduce the number of unnecessary transfusions, such as a PBM programme, are therefore of great interest in improving patient safety. Although a relatively new and evolving concept, increased adoption of PBM around the world is expected given the benefits it offers for both patients and hospitals. These include shorter stays in intensive care units and in hospital, and overall reduced healthcare costs including a reduction in the cost (and volume) of blood products used during procedures.

What is PBM?

PBM is a multidisciplinary, evidence-based approach to individualising patient care which is now recommended by many medical societies. “The objectives of PBM are primarily patient-centred,” says Professor Haas. “Our goal is to use point-of-care diagnostics and targeted bleeding management in order to minimise the use of blood products and improve patient outcomes.”

Professor Haas and his team use viscoelastic testing as a preferred option to guide their bleeding management. “PBM is an inter-disciplinary approach, which tries to optimise patients’ care in terms of blood transfusion. So, our basic goal is to reduce the amount of transfused blood products by lowering the intra-operative blood loss,” he explains. In other words, finding the optimal intervention for each individual patient and each surgery. Avoiding blood transfusion can be very straightforward. “In some cases, simply supplementing iron in a preoperative patient suffering from iron deficiency anaemia can remove the need for transfusion,” remarks Professor Haas.

Professor Keyvan Karkouti MD, FRCPC, MSc (who is Chief of the Department of Anaesthesia and Pain Management for the University Health Network/Sinai Health System/Women's College Hospital in Toronto, Canada) shares a similar view:

“PBM aims to improve patient outcomes and safety by reducing the need for red blood cell and other blood product transfusions and/or by supporting patients’ own reserves.”

Targeted point-of-care bleeding management

An emerging area of study is in the use of fibrinogen, also known as factor I, in lieu of whole blood to facilitate clotting. Fibrinogen is a glycoprotein that occurs naturally in plasma and is essential in binding blood platelets to form blood clots. This is critical for stopping excessive bleeding resulting from various traumatic injuries, or during surgery.

Fibrinogen is the first factor to become deficient during perioperative bleeding or trauma and is often the only deficiency that needs to be treated.

“Fibrinogen concentrate allows the administration of a precise dose to reach your desired target level. It is immediately available, and it has a really excellent safety profile,” confirms Professor Haas. “In bleeding patients with hypofibrinogenaemia, administration of fibrinogen concentrate is always our first choice.”

Unlike with rare congenital fibrinogen deficiency, acquired fibrinogen deficiency arises when excessive blood loss and consequent clotting caused by trauma or major surgery uses up fibrinogen reserves in the blood. “If you follow a targeted, point of care bleeding management strategy, you can supplement those factors that are actually needed,” explains Professor Karkouti, continuing, “Fibrinogen is chief among those that need to be addressed.”

“When running a viscoelastic test such as a thromboelastometry, in many cases we can identify that acquired fibrinogen deficiency is the main and only underlying problem, and therefore reduce transfusions”, remarks Professor Haas.

A high-purity human fibrinogen concentrate

Octapharma has conducted several studies investigating replacement of fibrinogen by its fibrinogen concentrate as an effective alternative to cryoprecipitate, a fraction of plasma. Cryoprecipitate is less pure, contains several coagulation factors and carries the risk of pathogen transmission, while Octapharma’s human fibrinogen concentrate is a virally inactivated highly purified fibrinogen concentrate with standardised content that allows precise dosing.

In November 2019, Octapharma's high-purity human fibrinogen concentrate received approval for its use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries, before receiving further approval for use in an additional 13 EU countries in 2020. Olaf Walter, Board Member at Octapharma, notes that “This approval greatly expanded the potential for using fibrinogen replacement in the management of bleeding, particularly in a surgical setting.”

Octapharma also provides educational programmes to raise awareness of PBM and supports the implementation. As Oliver Hegener, VP Head of IBU Critical Care describes: “Octapharma is committed to raising awareness of PBM within the medical community, particularly among those anaesthesiologists and intensivists who want to go the next steps towards individualised treatment solutions for improved outcome and safety.”