Enabling innovation in bleeding management and critical care

Lachen, Switzerland
Innovation and science
Critical care

“Critical medical conditions in combination with lifethreatening bleeding in trauma or surgery require effective interventions such as carefully managed coagulation therapy.”

Oliver Hegener
Head of International Business Unit Critical Care, Octapharma

Bleeding remains the leading cause of preventable death following major trauma and is a significant challenge in surgical and post-operative care.1 Octapharma has made significant contributions to improving standards of critical care and developing new treatments for coagulation management.

“Critical medical conditions in combination with life-threatening bleeding in trauma or surgery require effective interventions such as carefully managed coagulation therapy,” explains Oliver Hegener, Critical Care, Octapharma. “Yet, the level of evidence and accepted standards are limited in this field, and patient outcomes can vary significantly.”

Bridging the treatment gap

Octapharma is partnering with leading medical centres across the USA and around the world to bridge this treatment gap and enhance the understanding and implementation of personalised approaches to manage bleeding.

“Our goal is to empower healthcare professionals to better manage lifethreatening bleeding more effectively,” Oliver explains. “This involves enriching the interventional toolkit with customised treatment options and generating the required evidence for refining strategies for administering blood products.”

“Effectively managing bleeding in critically ill patients necessitates a patient-centric, multi-disciplinary approach and a shared understanding among various medical specialties to guarantee the bestindividualised care for each patient."

Oliver Hegener, Head of International Business Unit Critical Care at Octapharma

“Effectively managing bleeding in critically ill patients necessitates a patient-centric, multi-disciplinary approach and a shared understanding among various medical specialties to guarantee the best individualised care for each patient.”

Oliver Hegener
Head of International Business Unit Critical Care at Octapharma

The right diagnostic tools

New diagnostic tools that enable the close monitoring of critical clotting factors, such as fibrinogen levels in a patient’s blood, are revolutionising bleeding management. These technological advancements make it possible for healthcare professionals to tailor patient care with specific coagulation factor agents.

In combination, improved diagnostics and specific coagulation factor concentrates have the potential to amend or even replace traditional blood products in transfusions, allowing for more customised care that maximises the efficient use of resources.

Enhanced accessibility to diagnostics, the required interventions and training is crucial for the implementation of modern, goal-directed therapies in the management of bleeding. To stimulate this development, Octapharma is collaborating with innovative providers of diagnostic technologies, the relevant authorities and medical experts with the mutual goal of routine implementation for every patient in need.

Expanding treatment options

Octapharma is committed to investing in R&D to enhance our established portfolio of factor replacement products and to widen the approved applications of these products.

Most recently, on August 27, 2023, Octapharma USA announced that the US FDA had given approval for the use of Octapharma’s four-factor prothrombin complex concentrate (4F-PCC). This product is specifically designed to reverse the effects of anticoagulants such as warfarin in adult patients who are undergoing surgery or invasive procedures.

Warfarin is a common anticoagulant prescribed to over 2.4 million patients in the USA alone. It is used to prevent blood clots following conditions such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism, after heart valve surgery, or with certain types of irregular heartbeats, like atrial fibrillation.

“The FDA approval of Octapharma's 4-factor prothrombin complex concentrate expands the therapy options for medical providers when their patients require a 4F-PCC product,” said Flemming Nielsen, President of Octapharma USA.

Enhancing paediatric care

Earlier in 2023, the FDA approved two supplements to Octapharma’s Biological License Applications. These approvals led to new labelling for two of its products: a pooled plasma (human) solvent/detergent (S/D) treated solution for intravenous infusion, and a fibrinogen (human) lyophilised powder for reconstitution. This notably broadens the range of critical care options available for children.

The new labelling for pooled S/D treated human plasma incorporates the findings from two post-marketing studies, LAS-212 and LAS-213. These studies evaluated the product’s efficacy, safety and tolerability in a paediatric population ranging from newborns to 20-year-olds. Furthermore, the FDA granted Octapharma’s request to extend the use of Octapharma's human fibrinogen concentrate. The product can now be used for on-demand treatment of acute bleeding episodes in patients under 12 years old who have congenital fibrinogen deficiency (CFD), also known as factor 1 deficiency.

Improving emergency response

In February 2023, European medical authorities approved a freeze-dried formulation of Octapharma’s well-established, pharmaceutically licensed and virally inactivated plasma for transfusion. This new line extension, set to be marketed in Europe as a powder and solvent for solution for infusion, introduces innovative and potentially life-saving treatment options for use in pre-hospital and emergency settings.

This innovative powder form of pooled S/D treated human plasma represents a breakthrough in addressing logistical challenges in emergency care. The ability to store the treatment at room temperature and reconstitute it on-site in early and pre-hospital settings allows a very early access to transfusion and significantly decreases the reaction time. It effectively overcomes the barriers posed by the lack of frozen storage facilities or cold chain infrastructure, which is needed for the storage and administration of frozen plasma products.

Vision for the future

Octapharma remains firmly focused on the future, continuously pioneering in the field of bleeding management.

Fibrinogen, the first factor to be depleted in massive bleeding scenarios, typically seen in trauma and surgery, is one of our key areas of interest. Octapharma introduced a highly purified fibrinogen concentrate for the use in both congenital and aquired fibrinogen deficiencies. This product has become increasingly vital in routine bleeding management interventions, aligning with global guideline recommendations. It offers patients a crucial factor replacement option, addressing a significant need in medical care.

To expand the accessibility of the high-purity human fibrinogen concentrate, Octapharma has conducted landmark trials in cardiac surgery. The encouraging results from these studies are currently in discussions with global regulators. The goal is to integrate human fibrinogen concentrate more routinely into major surgical procedures, particularly in cardiovascular operations.

Octapharma is also actively engaged in initiatives related to anticoagulation management, trauma care and congenital factor deficiencies. Through ongoing R&D, we aim to bring about substantial improvements in bleeding management for critically ill patients. The company’s focus is on enhancing the overall quality of care, aiming to reduce mortality rates and striving to minimise the complications associated with massive bleeding.

Anticoagulants reversal prior emergency surgery

A questionnaire covering anticoagulants reversal prior emergency surgery was sent to American Society of Anesthesiology members.2

Key findings:

  1. Fresh frozen plasma is used more than Prothrombin complex concentrates

  2. Unified guideline-based institutional algorithms and management protocols are needed

32% of institutions had emergency anticoagulant reversal protocols. Only 13% of respondents coordinated management with haematologists during their patient evaluation.


1. Cannon JW. Hemorrhagic Shock. N Engl J Med. 2018;378(4):370-379. doi:10.1056/NEJMra1705649 – PubMed

2. onlinelibrary.wiley.com/doi/full/10.1002/rth2.12320


Annual report

Bleeding management

Critical care