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Managing fibrinogen deficiency in peri-operative bleeding situations

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In the absence of specific guidance on fibrinogen replacement, the following information refer to fibrinogen-related recommendations in established guidelines and expert recommendations on perioperative bleeding management in acquired fibrinogen deficiency (AFD), as well as preventing and managing severe bleeding in congenital fibrinogen deficiency (CFD).

Fibryga® therapeutic indications: As complementary therapy to management of uncontrolled severe haemorrhage in patients with acquired hypofibrinogenaemia in the course of surgical intervention. Treatment of bleeding episodes and peri-operative prophylaxis in patients with congenital hypo- or afibrinogenaemia with bleeding tendency.
Fibryga® therapeutic indications: As complementary therapy to management of uncontrolled severe haemorrhage in patients with acquired hypofibrinogenaemia in the course of surgical intervention. Treatment of bleeding episodes and peri-operative prophylaxis in patients with congenital hypo- or afibrinogenaemia with bleeding tendency.

Please visit the efficacy and safety page to review the clinical data for fibryga in AFD and CFD.

Managing risk for transfusion-related complications

As with all interventions in medicines, the use of any fibrinogen replacement therapy requires a balance of its risk-benefit profile. All transfusions carry risk.1 Major bleeding related to surgery, trauma or obstetrics are all indications for massive transfusion.2 Patients who receive a blood transfusion have a dose-related increased risk of death, organ dysfunction, length of critical care, and hospital stay.3

  • In the UK, blood donation is a voluntary process. People who have had a blood transfusion are not currently able to donate blood.4

  • As the NHS Blood and Transplant (NHSBT) faces blood supply challenges5, there is a greater case to be made for reducing the number of unnecessary transfusions as recommended by the final report from the Infected Blood Inquiry (IBI)6 and by the 2024 report from the Serious Hazards of Transfusion (SHOT) scheme.7

IBI and SHOT Reports

Background to the IBI

The Infected Blood Inquiry (IBI) examined the circumstances in which patients treated by the NHS before 1996 received infected blood and blood products.8

Relevant recommendations from the IBI21

Reducing transfusion-related infections Focus on use and unnecessary transfusions reducing blood component Use to reduce the risk of major bleeding, as already seen in obstetrics and cardiac settings tranexamic acid on blood components, their indications for use, available, risks, benefits, possible reactions and management Train staffalternative options Implement recommendations of the Serious Hazards of Transfusions (SHOT) report
Reducing transfusion-related infections Focus on use and unnecessary transfusions reducing blood component Use to reduce the risk of major bleeding, as already seen in obstetrics and cardiac settings tranexamic acid on blood components, their indications for use, available, risks, benefits, possible reactions and management Train staffalternative options Implement recommendations of the Serious Hazards of Transfusions (SHOT) report

Background to SHOT

SHOT is the UK’s independent, professionally-led haemovigilance scheme9

  • Since 1996 SHOT has collected and analysed anonymised information on adverse events and reactions in blood transfusion from all healthcare organisations that are involved in the transfusion of blood and blood components in the UK9

  • Where risks and problems are identified, SHOT produces recommendations to improve patient safety and includes these in its annual report9

SHOT identifies areas where laboratory and clinical practice need to be improved and makes appropriate recommendations for changes that will improve outcomes for patients9

Key findings from the 2024 SHOT report7

Delayed transfusions were the 4th leading cause of major morbidity in 2024

%

FAHR (113/190)

%

TACO (32/190)

%

HTR (14/190)

%

delayed transfusions (12/190)

Avoidable and delayed transfusions have been increasing

%

yearly increase in avoidable transfusions (170 vs 127 in 2023)

%

yearly increase in delayed transfusions (312 vs 212 in 2023)

Avoidable errors accounted for most of the reports submitted to SHOT (3,222/3,998; 83.1%).

Key recommendations from the SHOT annual report 20247

Reducing transfusion-related risks All staff involved in the transfusion pathway need to have , appropriate to their role, of , , , , and their relevant knowledgeblood componentsindications for usealternate options availablerisks and benefitspossible reactionsmanagement ²² ²² Unnecessary transfusions must be avoided
Reducing transfusion-related risks All staff involved in the transfusion pathway need to have , appropriate to their role, of , , , , and their relevant knowledgeblood componentsindications for usealternate options availablerisks and benefitspossible reactionsmanagement ²² ²² Unnecessary transfusions must be avoided

Recommendations for reducing the risk of transfusion-related complications

²¹  IBI 2024 ²²  SHOT 2024 Focus on reducing blood component use and unnecessary transfusions Train staff on blood components, their indications for use, alternative options available, risks, benefits, possible reactions and management
²¹  IBI 2024 ²²  SHOT 2024 Focus on reducing blood component use and unnecessary transfusions Train staff on blood components, their indications for use, alternative options available, risks, benefits, possible reactions and management

Managing hypofibrinogenaemia in a major haemorrhage

UK and European guidelines on the management of major haemorrhage recommend fibrinogen replacement therapy when fibrinogen levels fall to <1.5 g/L10-14 (or <2.0 g/L in obstetric haemorrhage).10-13

Guideline


 Association of Anaesthetists (2025) – The use of blood components and their alternatives ¹⁰ , 
 



 (AoA) British Society for Haema-tology (2022) – Haematologicalmanagement of major haemorrhage ¹¹ , 
 (BSH) European Society of Anaes-thesiology and Intensive Care (2022) – Management of severe peri-operative bleeding ¹² , (ESAIC) European Association for Cardio-Thoracic Surgery / European Association for Cardiothoracic Anaesthesiology and Intensive Care (2024) – Patient blood manage-ment in adult cardiac surgery in collaboration with EBCP ¹³ , (EACTS)(EACTAIC) Pan-European, multidisciplinary (2023) – management of major bleeding and coagulopathy following trauma: 6 edition th¹⁴ , Task Force for Advanced Bleeding Care in Trauma Threshold for initiating fibrinogen replacement <1.5 g/L <2.0 g/L in obstetric haemorrhage*









 <1.5 g/L 
(non-pregnant women*) <2.0 g/L 
in pregnant women* 

 <1.5 g/L
<2.0 g/L in obstetric haemorrhage*
 

 

 <1.5 g/L

















 <1.5 g/L





 




 Recommendation


 Highlights that for the perioperative management of uncontrolled severe haemorrhage in patients with in addition to its licence. As such, its use in the acquired setting is not off-label. Although there are no currently published superiority clinical effectiveness data for fibryga over cryoprecipitate, usage should be balanced against its putative benefits (logistical advantages, storage requirement, preparation times). ¹⁰¹⁵¹⁵ ,,, fibryga® is also licensedacquired hypofibrinogenaemia,congenital fibrinogen deficiency Clinical data does not support one form of fibrinogen replacement over the other.Fibrinogen concentrate may be considered as an for the management of bleeding in patients. fibrinogen concentrate may in-crease fibrinogen in an adult by ~1.0 g/L. ¹¹¹¹¹¹ , , , alternative to cryoprecipitate4-5g Supports use of fibrinogen concentrate for intra-operative or post-operative bleeding accompanied by hypofibrinogenaemia in and surgery. During massive transfusion, fibrinogen concentrate may compared with FFP. Recommends a which is beneficial in reducing exposure to allogeneic blood products. ¹²¹²¹² ,,, cardiac, hepatic, obstetricpaediatricreduce the risk of fluid overloadrestrictive transfusion strategy, Consider fibrinogen replacement to when low fibrinogen level is accompanied with microvascular bleeding. ¹³ ,














 reduce the requirement for transfusions Recommends use of fibrinogen concen-trate or cryoprecipitate if is accompanied by hypo-fibrinogenaemia.When using fibrinogen concentrate, suggests an initial fibrinogen supplemen-tation of 




 ¹⁴¹⁴ , trauma-related major bleeding3–4g. Use of PoCT recommended?

 (in patients with active bleeding during surgery). ¹⁰ , 








 YES (in cardiac surgery). ¹¹ ,
 


 
 YES (in cardiac surgery and liver transplan-tation). Highlights its benefit in and in PPH. ¹²¹² ,, YESidentifying coagulopathyreducing transfusion requirement ¹³ ,

















 YES (early and repeated). ¹⁴ ,

 






 YES ¹¹ , * During pregnancy, fibrinogen levels increase (range of 4–6 g/L at delivery vs. 2–4 g/L when non-pregnant)
Guideline


 Association of Anaesthetists (2025) – The use of blood components and their alternatives ¹⁰ , 
 



 (AoA) British Society for Haema-tology (2022) – Haematologicalmanagement of major haemorrhage ¹¹ , 
 (BSH) European Society of Anaes-thesiology and Intensive Care (2022) – Management of severe peri-operative bleeding ¹² , (ESAIC) European Association for Cardio-Thoracic Surgery / European Association for Cardiothoracic Anaesthesiology and Intensive Care (2024) – Patient blood manage-ment in adult cardiac surgery in collaboration with EBCP ¹³ , (EACTS)(EACTAIC) Pan-European, multidisciplinary (2023) – management of major bleeding and coagulopathy following trauma: 6 edition th¹⁴ , Task Force for Advanced Bleeding Care in Trauma Threshold for initiating fibrinogen replacement <1.5 g/L <2.0 g/L in obstetric haemorrhage*









 <1.5 g/L 
(non-pregnant women*) <2.0 g/L 
in pregnant women* 

 <1.5 g/L
<2.0 g/L in obstetric haemorrhage*
 

 

 <1.5 g/L

















 <1.5 g/L





 




 Recommendation


 Highlights that for the perioperative management of uncontrolled severe haemorrhage in patients with in addition to its licence. As such, its use in the acquired setting is not off-label. Although there are no currently published superiority clinical effectiveness data for fibryga over cryoprecipitate, usage should be balanced against its putative benefits (logistical advantages, storage requirement, preparation times). ¹⁰¹⁵¹⁵ ,,, fibryga® is also licensedacquired hypofibrinogenaemia,congenital fibrinogen deficiency Clinical data does not support one form of fibrinogen replacement over the other.Fibrinogen concentrate may be considered as an for the management of bleeding in patients. fibrinogen concentrate may in-crease fibrinogen in an adult by ~1.0 g/L. ¹¹¹¹¹¹ , , , alternative to cryoprecipitate4-5g Supports use of fibrinogen concentrate for intra-operative or post-operative bleeding accompanied by hypofibrinogenaemia in and surgery. During massive transfusion, fibrinogen concentrate may compared with FFP. Recommends a which is beneficial in reducing exposure to allogeneic blood products. ¹²¹²¹² ,,, cardiac, hepatic, obstetricpaediatricreduce the risk of fluid overloadrestrictive transfusion strategy, Consider fibrinogen replacement to when low fibrinogen level is accompanied with microvascular bleeding. ¹³ ,














 reduce the requirement for transfusions Recommends use of fibrinogen concen-trate or cryoprecipitate if is accompanied by hypo-fibrinogenaemia.When using fibrinogen concentrate, suggests an initial fibrinogen supplemen-tation of 




 ¹⁴¹⁴ , trauma-related major bleeding3–4g. Use of PoCT recommended?

 (in patients with active bleeding during surgery). ¹⁰ , 








 YES (in cardiac surgery). ¹¹ ,
 


 
 YES (in cardiac surgery and liver transplan-tation). Highlights its benefit in and in PPH. ¹²¹² ,, YESidentifying coagulopathyreducing transfusion requirement ¹³ ,

















 YES (early and repeated). ¹⁴ ,

 






 YES ¹¹ , * During pregnancy, fibrinogen levels increase (range of 4–6 g/L at delivery vs. 2–4 g/L when non-pregnant)

Curious to see how this translates to clinical practice?

Contact us today to explore how other UK centres are using fibryga® to manage AFD in cardiac surgery, obstetrics, trauma, vascular and liver transplant.
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Managing severe bleeding in patients with congenital fibrinogen deficiency

The British Committee for Standards in Haematology (BCSH) has defined scenarios where fibrinogen replacement can be considered for preventing and managing severe bleeding in patients with congenital fibrinogen deficiency.16

Below are the recommendations in line with the licensed indication for fibryga®:

Guideline

 on behalf of the British Committee for Standards in Haematology (2014) – The diagnosis and management of the rare coagulation disorders. ¹⁶ UKHCDO(BCSH) Threshold for initiating fibrinogen replacement <1.0 g/L
or <0.1 g/L, when using prophylactically in cases with a history of severe bleeding

 Recommendation

 Fibrinogen concentrate can be considered for (afibrinogenaemia hypofibrinogenaemia), to maintain fibrinogen activity >1.0 g/L If fibrinogen concentrate is unavailable, pathogen-reduced cryoprecipitate can be considered but has and may be associated with or ¹⁶ , severe bleeding or major surgery in congenital fibrinogen deficiencygreater variation in fibrinogen content than fibrinogen concentratetransfusion reactionsvolume overload. or
Guideline

 on behalf of the British Committee for Standards in Haematology (2014) – The diagnosis and management of the rare coagulation disorders. ¹⁶ UKHCDO(BCSH) Threshold for initiating fibrinogen replacement <1.0 g/L
or <0.1 g/L, when using prophylactically in cases with a history of severe bleeding

 Recommendation

 Fibrinogen concentrate can be considered for (afibrinogenaemia hypofibrinogenaemia), to maintain fibrinogen activity >1.0 g/L If fibrinogen concentrate is unavailable, pathogen-reduced cryoprecipitate can be considered but has and may be associated with or ¹⁶ , severe bleeding or major surgery in congenital fibrinogen deficiencygreater variation in fibrinogen content than fibrinogen concentratetransfusion reactionsvolume overload. or

Why choose fibryga® for fibrinogen replacement?

Fibryga® is an effective fibrinogen replacement choice. Learn more about the clinical data.
Safety & Efficacy

UK-FIB-2500023 | April 2026

Abbreviations
AFD, acquired fibrinogen deficiency; AoA, Association of Anaesthetists; BHS, British Society for Haematolog; CFD, congenital fibrinogen deficiency; FGA, gene encoding alpha chain of fibrinogen; FGB, gene encoding beta chain of fibrinogen; FGG, gene encoding gamma chain of fibrinogen; UKHCDO, United Kingdom Haemophilia Centre Doctors’ Organisation; GI, gastrointestinal; FFP, fresh frozen plasma; FXIII, coagulation factor XIII; IU, international units; POCT, point-of-care testing; PBM, patient blood management; ROTEM, rotational thromboelastometry; TEG, thromboelastography; VHA, viscoelastic haemostatic assays; WFI, water for injection.

References

  1. Suddock JT, et al. Transfusion Reactions. 2023. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025. Available at: https://www.ncbi.nlm.nih.gov/books/NBK482202/. Accessed May 2026.

  2. Shah A, et al. Major haemorrhage: past, present and future. Anaesthesia. 2023;78:93-104.

  3. Clevenger B, Kelleher A. Hazards of blood transfusion in adults and children. Continuing Education in Anaesthesia Critical Care & Pain. 2014;14:112–18.

  4. NHS Blood and Transplant. Transfusion FAQs. Available at: https://www.nhsbt.nhs.uk/what-we-do/blood-services/blood-transfusion/transfusion-faqs/. Accessed May 2026.

  5. Chowdhury F, et al. Mitigating the impact of blood shortages in England. Br J Haem 2024;204:1660–71.

  6. Langstaff B. Infected blood inquiry. The report. Overview and recommendations. 2024. Available at: https://www.infectedbloodinquiry.org.uk/sites/default/files/Volume_1.pdf. Accessed May 2026.

  7. Narayan, S. et al., 2024. The 2024 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering Group. Available at: https://www.shotuk.org/shot-reports/annual-shot-report-2024/. Accessed May 2026.

  8. The Hepatitis C Trust (2025). The Infected Blood Inquiry. Available at: https://www.hepctrust.org.uk/find-support/infected-blood-and-blood-products/infected-blood-inquiry/. Accessed May 2026.

  9. SHOT (Serious Hazards of Transfusion). https://www.shotuk.org/about/what-we-do/.  Accessed May 2026.

  10. Shah A, et al. Association of Anaesthetists guidelines: the use of blood components and their alternatives. Anaesthesia. 2025;80:425–47.

  11. Stanworth SJ, et al. Transfusion Task Force of the British Society for Haematology. Haematological management of major haemorrhage: a British Society for Haematology Guideline. Br J Haematol. 2022;198:654–67.

  12. Kietaibl S, et al. Management of severe peri-operative bleeding: guidelines from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023;40:226–304.

  13. Casselman FPA, et al. 2024 EACTS/EACTAIC Guidelines on patient blood management in adult cardiac surgery in collaboration with EBCP. Eur J Cardiothorac Surg. 2025;67(5):ezae352.

  14. Rossaint, R, et al. The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition. Crit Care. 2023;27:80.

  15. Shah A, et al and the and the Association of Anaesthetists' Working Party for the use of blood components and their alternatives. Clarifying the role of fibrinogen concentrate in major haemorrhage: a reply. Anaesthesia. 2025;80: 1015–16.

  16. Mumford AD, et al. Guideline for the diagnosis and management of the rare coagulation disorders: a United Kingdom Haemophilia Centre Doctors' Organization guideline on behalf of the British Committee for Standards in Haematology. Br J Haematol. 2014;167:304–26.

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