CAUTION: Refer to the Document Library for the most recent version of this document. Cryoprecipitate Transfusion Guideline for Practice.

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1 Directorate Department Year Version Number Central Index Number Endorsing Committee Date Endorsed Approval Committee Date Approved Author Name and Job Title Key Words (for search purposes) Date Published on Document Library Review Date Target Audience Cancer, Diagnostics & Clinical Services Pathology 2015 Version 3 C0330 Quality Governance Operational Committee 12/07/2016 Hospital Transfusion Committee 08/06/2016 Hospital Transfusion Team:- Dr M Sivakumaran, Consultant Haematologist Chris Jones, Transfusion Lab Manager Kaye Bowen, Transfusion Practitioner Cryo; coagulopathy; fibrinogen 13/07/ /07/2019 All staff involved in prescribing and administering blood components Central Index Number: C0330 Version 3 Page 1 of 17

2 DOCUMENT VERSION CONTROL SCHEDULE Year and Version Number 2009 Version Version Version 3 Date Published on Document Library Revisions from previous issue Date of Endorsement May 2009 Original version of document April 2009 February /07/2016 Review led by Hospital Transfusion Team. Re formatted into current trust procedural documents format Review led by Hospital Transfusion Team. NICE guidance on indications for use incorporated. Advice on Hepatitis E negative components included. 27/02/2013 / Quality Governance Operational Committee 12/07/2016 / Quality Governance Operational Committee Central Index Number: C0330 Version 3 Page 2 of 17

3 Key Points Cryoprecipitate is the cryoglobulin fraction of plasma obtained by thawing a single donation of FFP at 4 +/- 2 C. Cryoprecipitate is rich in Factor VIII, von Willebrand factor and Fibrinogen. The indications for its use are limited but are primarily to provide fibrinogen to prevent bleeding due to coagulopathy. Cryoprecipitate is stored frozen (-30 C) and is defrosted in preparation for patient use. At least 30 minutes should be allowed from the time of request to issue to permit appropriate thawing. Cryoprecipitate for patients born after 1st Jan 1996 is collected from non UK donors, to reduce the risk of transmission of variant CJD. It is virally inactivated by treatment with Methylene Blue or solvent detergent, to reduce the risk of transmission of pathogens Central Index Number: C0330 Version 3 Page 3 of 17

4 Contents Section Page Number 1 Introduction 5 2 Purpose 5 3 Scope 5 4 Definitions of terms 5 5 Indications for use of cryoprecipitate 6 6 Dose and Group 6 7 Hepatitis E virus (HEV) Negative components 7 8 Administration 8 9 Endorsement 9 10 Distribution 9 11 References 9 12 Associated documents 10 Appendices 1 NHS Blood and Transplant Factsheet- Cryoprecipitate 11 2 Hepatitis E Virus- Factsheet for patients 15 3 Quality Assurance Checklist 17 Central Index Number: C0330 Version 3 Page 4 of 17

5 1. Introduction 1.1 Cryoprecipitate is the cryoglobulin fraction of plasma obtained by thawing a single donation of Fresh Frozen Plasma (FFP) at 4 +/- 2 C. 1.2 Cryoprecipitate is rich in Factor VIII, von Willebrand factor and fibrinogen. The indications for its use are limited but are primarily to provide fibrinogen to prevent bleeding due to coagulopathy. 1.3 The risks of transmitting infection are similar to those of other UK blood components. Of particular concern are allergic reactions and anaphylaxis, transfusion related acute lung injury (TRALI) and haemolysis from transfused antibodies to blood group antigens especially A and B. 1.4 Cryoprecipitate is produced from FFP from voluntary blood donations collected in the UK. However, cryoprecipitate for use in patients born after 1st Jan 1996 is produced from FFP donated by non UK donors, which is then treated with Methylene Blue to reduce the risk of transmission of pathogens. This measure is designed to reduce the slight possible risk of transmission of variant Creutzfeldt Jacobs Disease (CJD), as those born after 1 January 1996 are unlikely to have been exposed via the food chain. 1.5 Cryoprecipitate is stored frozen (-30 C) and is defrosted in preparation for patient use. At least 30 minutes should be allowed from the time of request to issue to permit appropriate thawing. 2. Purpose 3. Scope The purpose of this document is to give guidance to clinical staff who may be involved in the requesting, prescription or administration of Cryoprecipitate in Peterborough and Stamford Hospitals NHS Foundation Trust. They aim to standardise use of cryoprecipitate across the trust in line with national guidelines. These guidelines apply to all members of staff involved with the prescription, handling and administration of Cryoprecipitate. 4. Definition of terms 4.1 FFP Fresh Frozen Plasma- Plasma produced from blood donations and stored at -30 C. 4.2 Cryoprecipitate the cryoglobulin fraction of plasma obtained by thawing a single donation of Fresh Frozen Plasma (FFP) at 4 C (+/- 2 C). Central Index Number: C0330 Version 3 Page 5 of 17

6 4.3 DIC Disseminated Intravascular Coagulation- An acquired syndrome characterised by activation of coagulation pathways, resulting in formation of intravascular thrombi and depletion of platelets and coagulation factors. 4.4 DDAVP desmopressin acetate (1-deamino-8-D-arginine vasopressin). 5. Indications for use of cryoprecipitate 5.1 Disseminated Intravascular Coagulation (DIC) in the presence of haemorrhage when fibrinogen <1g/L. 5.2 Liver Disease with bleeding or pre surgery when fibrinogen <1g/L. 5.3 Bleeding associated with thrombolytic therapy causing hypofibrinogenaemia. 5.4 Massive transfusion maintain fibrinogen >1.5g/L. 5.5 Renal failure or liver failure with abnormal bleeding where DDAVP not appropriate. 5.6 Inherited hypofibrinogenaemia when concentrate not available. 5.7 Consider cryoprecipitate transfusions for patients without major haemorrhage who have: Clinically significant bleeding and A fibrinogen level below 1.5 g/litre. 5.8 Do not offer cryoprecipitate transfusions to correct the fibrinogen level in patients who: Are not bleeding and Are not having invasive procedures or surgery with a risk of clinically significant bleeding. 5.9 Consider prophylactic cryoprecipitate transfusions for patients with a fibrinogen level below 1.0 g/litre who are having invasive procedures or surgery with a risk of clinically significant bleeding. 6. Dose and Group 6.1 Cryoprecipitate is issued in pre pooled packs -1 pooled pack is equivalent to 5 single donor units. Paediatric packs are available and contain approx 30mls. 6.2 An adult therapeutic dose is 2 pools of five units, which contains 3-3.5g of fibrinogen and will raise the plasma fibrinogen level by about 1g/L. 6.3 For children, the recommended dose is 5 10 ml/kg body weight, up to a maximum of 2 pools. Central Index Number: C0330 Version 3 Page 6 of 17

7 6.4 Patients born after 1st January 1996 should only receive pathogen reduced cryoprecipitate, this is Methylene blue treated FFP from non-uk donors. 6.5 Group compatible cryoprecipitate should be used where possible. Cryoprecipitate which is not of the same ABO group should only be used if it contains no high-titre anti A or anti B. 6.6 RhD (D) positive Cryoprecipitate may be given to RhD (D) negative females of child bearing potential. Anti D prophylaxis is not required. 6.7 The prescription should ideally be made on the dedicated blood product prescription chart. For adults the prescription must indicate the number of pools to be administered. In paediatrics, this must be in mls/kg body weight. 6.8 Reassess the patient's clinical condition, repeat the fibrinogen level measurement and give further doses if needed. 7. Hepatitis E virus (HEV) Negative components 7.1 The hepatitis E virus (HEV) is found throughout the world in both humans and animals, especially pigs. A study carried out by NHS Blood and Transplant in 2012/13 showed that approximately 1 in 3000 blood donors in the south of England had HEV at the time of donation. 7.2 The majority of people who become infected with HEV have no symptoms and the infection clears completely within a couple of months. HEV may however pose a risk of harm to immunocompromised patients; they may be unable to clear the infection, which may then become persistent, potentially leading to chronic inflammation of the liver and cirrhosis. 7.3 While the risk of HEV to the general population is negligible, the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) has now recommended that certain patient groups who are immunocompromised / immunosuppressed should receive HEV negative blood components i.e.: components manufactured from donations that have been tested and confirmed as negative for HEV. This includes: Patients awaiting solid organ transplant (SOT) from3 months prior to date of planned elective SOT or from the date of listing. Patients who have had SOT for as long as the patient is taking immunosuppressant s. Patients with acute leukaemia from diagnosis (unless/until a decision is made not to proceed with stem cell transplant). Patients awaiting allogeneic stem cell transplant from 3 months prior to the date of planned transplant and up to 6 months following transplant, or for as long as the patient is immunosuppressed. Extra corporeal procedures such as dialysis or extra-corporeal circulatory support for SOT patients or SOT patients receiving immunosuppressive medication. Central Index Number: C0330 Version 3 Page 7 of 17

8 7.4 All MB cryoprecipitate components are HEV negative. NHSBT will also provide HEV negative components for neonates and infants under the age of one year. 7.5 For some patients, HEV negative blood components may only be needed for a short period of time, usually until the immune system is back to working as normal. 7.6 Anyone requesting blood components for a patient must answer yes to Special Products required? on the ICE request form and also contact transfusion on 8451/2 (bleep 1151 out of hours) to inform them that HEV negative components are required. They should also include the requirement for HEV negative blood components in the clinical information given on the request form. 7.7 In an urgent/emergency situation, clinicians should liaise with the transfusion laboratory regarding how long it will take them to issue HEV negative components for the patient. If this requirement cannot be met in time, you should discuss other options with the laboratory and the patient, if appropriate, as components not confirmed as HEV negative may need to be used. If blood components not confirmed as HEV negative are given, the patient should be managed as if they have potentially been exposed to HEV. 7.8 It is vital that the transfusion laboratory is informed of the patient s requirement for HEV negative components as soon as it is identified, as well as the nursing team looking after the patient, and also any other hospital who might be sharing care of the patient. The requirement for HEV negative components should also be discussed with the patient. Hepatitis E Virus - Factsheet for Patients is available (Appendix 1) 8. Administration 8.1 Cryoprecipitate must be administered through a µm filter (a standard blood giving set). A filter is required for the giving of cryoprecipitate via a syringe for neonatal transfusion. 8.2 The cryoprecipitate pack should be visually inspected for pack integrity and discolouration prior to transfusion. Check that packs do not appear grainy or more cloudy than usual. If in doubt, DO NOT TRANSFUSE and contact the transfusion laboratory for advice. 8.3 All patients receiving cryoprecipitate must wear a trust ID band. The patient s identity must be checked by 2 members of staff prior to commencement of the transfusion. The details on the tag attached to the pack must be checked against the details on the patients ID band. In addition, the patient should be asked to confirm their name and date of birth, if they are able to do so. 8.4 Cryoprecipitate takes approximately minutes to thaw and for maximum efficacy should be administered as soon as possible after thawing. Start the transfusion as soon as the pack is received from the laboratory. Cryoprecipitate Central Index Number: C0330 Version 3 Page 8 of 17

9 is stored at room temperature when thawed and must be used within 4 hours of thawing- there will be a note to this effect on the compatibility form issued with the pack. Cryoprecipitate must never be refrigerated, as this will cause re- precipitation. 8.5 In adults each pack should be given over minutes, though more rapid infusion may be required in major bleeding. In paediatrics, the recommended rate of transfusion is 10-20ml/kg/hr. 8.6 Inform the patient of possible complications of transfusion, and the importance of reporting any adverse effects. A number of reactions may follow cryoprecipitate transfusions. They are the same as those which can occur after the transfusion of red cell concentrates including:- Febrile Reactions. Urticarial Reactions. Anaphylactic Reactions. Reaction to a bacterially contaminated unit. 8.7 Follow the same baseline, 15 minute and post transfusion observation checks as for red cell transfusions. If a reaction is suspected, STOP THE TRANSFUSION, and inform medical staff and the transfusion laboratory immediately. An adverse event and transfusion reaction form must be completed. 9. Endorsement This guideline will be approved by the Hospital Transfusion Committee & endorsed by the Quality Governance Operational Committee. 10. Distribution This guideline will be available on share Point, on the trust intranet. 11. References British Committee for Standards in Haematology (2004) Guidelines for the use of Fresh Frozen Plasma, Cryoprecipitate and Cryosupernatant. Available: [Accessed 09/05/2016]. British Committee for Standards in Haematology (2005) Amendment to the Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant (selection according to ABO and RhD grouping) Available: pdf [Accessed 09/05/2016]. British Committee for Standards in Haematology (2007) Amendment to the guidelines for the use of fresh-frozen plasma, cryoprecipitate and Central Index Number: C0330 Version 3 Page 9 of 17

10 cryosupernatant (clarification on storage after thawing), BCSH Transfusion Task Force. Available from: df [Accessed 09/05/2016]. British Committee for Standards in Haematology (2007) Amendment to the transfusion guidelines for neonates and older children (specification of imported FFP). Available from ct_2007.pdf [Accessed 09/05/2016]. National Institute for Health and Care Excellence (2015) Blood Transfusion Available; [Accessed 09/05/2016]. Norfolk, D (ed) (2013). Handbook of Transfusion Medicine, 5th edition. Norwich: TSO. Available: [Accessed 09/05/2016]. SaBTO - Advisory committee on the Safety of Blood Tissues and Organs (2015) Hepatitis E Virus and Allogenic Stem cell Transplantation. Available: 12_08_15.pdf [Accessed 09/05/2016] 12. Associated documents Blood Transfusion Policy. Guideline for Management of Massive blood loss. Policy for Competency Assessment of Staff Handling Collecting and/or Administering Blood and Blood Components. Central Index Number: C0330 Version 3 Page 10 of 17

11 Appendix 1 NHS Blood and Transplant Factsheet- Cryoprecipitate Central Index Number: C0330 Version 3 Page 11 of 17

12 Central Index Number: C0330 Version 3 Page 12 of 17

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15 Appendix 2 Hepatitis E Virus- Factsheet for patients Central Index Number: C0330 Version 3 Page 15 of 17

16 Central Index Number: C0330 Version 3 Page 16 of 17

17 Quality Assurance Checklist - Version Number: 3 Appendix: 3 Y/N/n/a 1 Title of document (C0330) 2 Type of document (e.g. guidance, code of practice) Guideline COMMENTS (where necessary) Is the title clear and unambiguous? Is it clear whether the document type is (e.g. guideline, procedure)? 3 Introduction Are reasons for the development of the document clearly stated? 4 Content Is there a standard front cover? Are the key points identified? Is the document in the correct format? Is the purpose of the document clear? 5 Approval Route Does the document identify which committee/group will approve it? 6 Review Date Is the review date identified? If answers to any of the above questions is no, then this document is not ready for endorsement, it needs further review. Compliance Team: 1. Date of Compliance Team approval 17/11/ Comments to author for any amendments 3. Name of compliance lead Jim Walker, Quality Governance & Policies Assistant Approval Committee: HTC If the committee/group is happy to approve this document would the chair please sign below and send the document and the minutes from the approval committee to the author. To aid distribution all documentation should be sent electronically wherever possible. Name Dr B Appadu Date 08/06/16 Signature Endorsing Committee: QGOC If the committee/group is happy to endorse this document would the chair please sign below and send the document and the minutes from the endorsing committee to the author. To aid distribution all documentation should be sent electronically wherever possible. Name Date Signature Central Index Number: C0330 Version 3 Page 17 of 17