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May 2022

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Are we closer to seeing the end of cryoprecipitate in Ontario?

Jeannie Callum, BA, MD, FRCPC
Director of Transfusion Medicine, Kingston Health Sciences Centre

In October of 2019, the results of the FIBRES trial were simultaneously released in both JAMA and at the plenary session of the AABB annual meeting.1 The conduct of the FIBRES trial was a major achievement for hospital blood bank technologists and cardiac surgical teams at 11 hospitals across Canada. The trial determined that fibrinogen concentrate was non-inferior to cryoprecipitate for hemostatic control of cardiac surgery-related bleeding and had a similar safety profile. In subgroup analysis, patients undergoing elective surgery were found to have superior hemorrhage control with fibrinogen concentrate, compared to cryoprecipitate. This was a major advance towards the transition to pathogen reduced blood products, which had been supported at the pathogen reduction consensus conference in Toronto in 2007.2 Indeed, Canadian Blood Services took Canada one step further in this important safety journey in 2022 with the introduction of pathogen-reduced platelet concentrates.

So where are we almost 30 months later after the publication of the FIBRES trial in the transition to a safer fibrinogen replacement product? Ontario turned on a dime after the FIBRES trial was published, with the number of cryoprecipitate units issued 8 weeks later in January 2020 already in half. In February of 2022, only 148 units or approximately 15 adult doses were issued to the remaining 12 hospitals in Ontario still ordering cryoprecipitate as a fibrinogen source. The majority of these 12 hospitals are non-academic hospitals, suggesting that process change rather than some inherent belief in the superiority of cryoprecipitate is resulting in a delay in transitioning. Change during COVID-19 is not easy. In addition, almost every transfusion laboratory is struggling with staffing due to shortages in medical laboratory technologists. A few of these 12 hospitals also have pediatric patients and are ordering single units suggesting reluctance to extrapolate the data from adult trials to pediatric patients. Fortunately, there have been two randomized trials comparing cryoprecipitate to fibrinogen concentrate in pediatric cardiac surgical patients with similar outcomes for efficacy and safety.3,4 One would hope we would prioritize pediatric patients to getting access to a safer fibrinogen replacement, since these patients are most likely to live long enough to be affected by a novel blood borne pathogen. Dr. Steven Kleinman estimated the economic impacts of a novel blood borne pathogen and the estimated number of affected patients in Canada; the estimates are staggering.5

In addition, to the paramount safety concern with the use of a non-pathogen reduced product when a safer product is available, cryoprecipitate has other negative characteristics we need to consider. First, Canadian Blood Services must collect B2-pack whole blood for their manufacture. Nancy Heddle has raised the concern in an article in Lancet Haematology in 2016 that the outcome for the recipient of these matching B2 red cells may be inferior.6 Second, when we utilize plasma for the manufacture of cryoprecipitate, the residual plasma cannot be used for either transfusion or for the manufacture of derivatives. Third, the B2 pack production line cannot be used to produce platelet concentrates. Fourth, cryoprecipitate is frozen and therefore cannot be easily redistributed if not used before impending expiration. Fifth, cryoprecipitate must be thawed and pooled before issue (along with a lot of computer clicks) delaying issue to hemorrhaging patients. This is also workload our dwindling supply of technologists must bear. Lastly, we have no idea what the patient safety risk of the impurities in cryoprecipitate may be for our patients (platelet microparticles, factor VIII, von Willebrand factor, etc.). Indeed, concern for an increased risk of thromboembolic complications has been raised by two papers.7,8

Dr. Judith Pool invented “Pool’s cryoprecipitate” in 1964 as a treatment for patients with congenital factor VIII deficiency.9 It later found a common use for acquired hypofibrinogenemia.10 Its use for the last 60 years for fibrinogen replacement has undoubtedly saved many lives, although unfortunately it has also been implicated in transmissible infections, including one high profile case (Blood money | Maclean’s | MARCH 28, 1994 (macleans.ca)). Most European countries have completed the transition to fibrinogen concentrates11 and it is reassuring to see that Ontario is almost there.

Figure 1. Units of cryoprecipitate issued to Ontario hospitals by month over the last 3 years.

References:

  • Callum J, Farkouh ME, Scales DC, Heddle NM, Crowther M, Rao V, Hucke HP, Carroll J, Grewal D, Brar S, Bussieres J, Grocott H, Harle C, Pavenski K, Rochon A, Saha T, Shepherd L, Syed S, Tran D, Wong D, Zeller M, Karkouti K, Group FR. Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial. JAMA 2019;322: 1966-76.
  • Webert KE, Cserti CM, Hannon J, Lin Y, Pavenski K, Pendergrast JM, Blajchman MA. Proceedings of a Consensus Conference: pathogen inactivation-making decisions about new technologies. Transfus Med Rev 2008;22: 1-34.
  • Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg 2014;148: 1647-55.
  • Downey LA, Andrews J, Hedlin H, Kamra K, McKenzie ED, Hanley FL, Williams GD, Guzzetta NA. Fibrinogen Concentrate as an Alternative to Cryoprecipitate in a Postcardiopulmonary Transfusion Algorithm in Infants Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial. Anesth Analg 2020;130: 740-51.
  • Kleinman S, Cameron C, Custer B, Busch M, Katz L, Kralj B, Matheson I, Murphy K, Preiksaitis J, Devine D. Modeling the risk of an emerging pathogen entering the Canadian blood supply. Transfusion 2010;50: 2592-606.
  • Heddle NM, Arnold DM, Acker JP, Liu Y, Barty RL, Eikelboom JW, Webert KE, Hsia CC, O’Brien SF, Cook RJ. Red blood cell processing methods and in-hospital mortality: a transfusion registry cohort study. Lancet Haematol 2016;3: e246-54.
  • Myers SP, Brown JB, Leeper CM, Kutcher ME, Chen X, Wade CE, Holcomb JB, Schreiber MA, Cardenas JC, Rosengart MR, Neal MD, group Ps. Early versus late venous thromboembolism: A secondary analysis of data from the PROPPR trial. Surgery 2019;166: 416-22.
  • Roy A, Stanford S, Nunn S, Alves S, Sargant N, Rangarajan S, Smith EA, Bell J, Dayal S, Cecil T, Tzivanakis A, Kruzhkova I, Solomon C, Knaub S, Moran B, Mohamed F. Efficacy of fibrinogen concentrate in major abdominal surgery – A prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei. J Thromb Haemost 2020;18: 352-63.
  • Swenson E, Hollenhorst MA. Dr Judith Graham Pool and the development of cryoprecipitate. Transfusion 2021;61: 1676-7.
  • Callum JL, Karkouti K, Lin Y. Cryoprecipitate: the current state of knowledge. Transfus Med Rev 2009;23: 177-88.
  • Nascimento B, Goodnough LT, Levy JH. Cryoprecipitate therapy. Br J Anaesth 2014;113: 922-34.

Password Managers can Help Protect your Hospital Network from Cyber Attacks

Andrew Duyvestyn, Information Technology Analyst
Ontario Regional Blood Coordinating Network

Cyber security in healthcare networks is increasingly important; the recent cyberattack on the Newfoundland and Labrador (N.L.) healthcare system is being referred to as the worst in Canadian history [1], and hospital networks in Ontario such as Humber River Hospital [2], Listowel, and Wingham [3] have also been victims of recent attacks. The cyberattack in N.L. alone resulted in thousands of medical procedures being cancelled [4]. While vulnerability exploitation was the largest cause of cyberattacks in 2021 at 47%, phishing was the second at 40%, according to the IBM X-Force Threat Intelligence Index 2022 [5]. 

The first step in an effective ransomware campaign starts with initial access, which is often done using a phishing campaign with the intent of gathering login credentials [5]. According to Tessa Anaya from GetApp, 55% of Canadians reuse passwords across accounts [6]. That means if one account is breached, all accounts are. Employees with access to hospital networks, systems, and applications are perfect targets for phishing campaigns, and are one of the most important lines of defence to keeping hospital networks secure as a result.

What can I do to help protect my hospital network?

  1. Be vigilant against phishing attacks.
    According to the Canadian Centre for Cyber Security [7], something may be “phishy” in an electronic communication if:
    • You don’t recognize the sender’s name, email address, or phone number (e.g. very common for spear phishing)
    • You notice a lot of spelling and grammar errors
    • The sender requests your personal or confidential information
    • The sender makes an urgent request with a deadline
    • The offer sounds too good to be true
  2. Use of a password manager.
    What is a password manager? A password manager is an application that stores all your passwords; it encrypts your login information and stores it securely on a server. That means if hackers gain access to the password manager’s system, the data the hackers access is unusable – they still won’t be able to access your accounts.

I remember my password, why should I use a password manager? 

Password managers allow you to store complex passwords without having to remember them. According to Hive Systems, an 18-character password made up of random numbers, uppercase and lowercase symbols, and symbols will take up to 438 trillion years for a hacker to crack with current available computing power, compared to only less than four minutes for a 10-character password made up of only lowercase letters. It is also important to note that if the password you are using has been previously cracked, hackers will be able to access your account immediately [8].

If your place of work is not yet using a password manager, we suggest you reach out to your IT team to request access to one. 1Password, for example, is a Toronto-based password manager that is HIPAA compliant and is the password manager of choice at the Ontario Regional Blood Coordinating Network.  

If you can remember your password, you need to change it! Set it and forget it with a password manager and protect your hospital network.

References:

[1] N.L. health-care cyberattack is worst in Canadian history, says cybersecurity expert (2021, November 04). CBC News. https://www.cbc.ca/news/canada/newfoundland-labrador/nl-cyber-attack-worst-canada-1.6236210

[2] Toronto hospital working to restore systems after being struck by cyber attack (2021, June 15). CTV News Toronto. https://toronto.ctvnews.ca/toronto-hospital-working-to-restore-systems-after-being-struck-by-cyber-attack-1.5471742

[3] Hospitals in Listowel and Wingham regain access to computer systems after ransomware attack (2019, October 28). CBC News. https://www.cbc.ca/news/canada/kitchener-waterloo/listowel-wingham-hospital-cyberattack-systems-back-online-1.5337910

[4] Cyberattack confirmed as cause of health-care disruptions in N.L.. (2021, November 03). CBC News. https://www.cbc.ca/news/canada/newfoundland-labrador/health-care-disruptions-day-5-1.6235229

[5] Singleton, C. et al. (2022, February). X-Force Threat Intelligence Index 2022. IBM Security. https://www.ibm.com/security/data-breach/threat-intelligence/

[6] Anaya, T. (2021, June 30). User authentication: 55% of Canadians reuse passwords across accounts. GetApp. https://www.getapp.ca/blog/2062/user-authentication-reuse-passwords

[7] Canadian Centre for Cyber Security. (2020, April). Don’t take the bait: Recognize and avoid phishing attacks. Government of Canada. https://cyber.gc.ca/en/guidance/dont-take-bait-recognize-and-avoid-phishing-attacks

[8] Neskey, C. (2022, March 02). Are Your Passwords in the Green?. Hive Systems. https://www.hivesystems.io/blog/are-your-passwords-in-the-green

Celebrating National Nursing Week

ORBCoN celebrates National Nursing Week, many thanks to every nurse for your compassion and dedication

See you at CSTM 2022

Hope to see you at the 2022 CSTM Conference and be sure to visit ORBCoN at our booth #114 !
Friendly members of our team will be available at the booth to network and answer any transfusion medicine questions you may have.

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