Prolonged prothrombin time and thrombocytopenia are common in patients with cirrhosis. These parameters do not reflect the overall hemostatic rebalance or bleeding risk in the periprocedural setting; however, attempts to correct these parameters remain frequent. We review the literature on periprocedural bleeding risk, bleeding risk factors, and the risk and benefits of hemostatic interventions in patients with cirrhosis. We provide guidance recommendations on evaluating bleeding risk in this patient group and management of hemostatic abnormalities in the periprocedural setting

Hernandez-Gea, Virginia

Lisman, Ton

Magnusson, Maria

Roberts, Lara N.

Stanworth, Simon

Thachil, Jecko

Tripodi, Armando

English

University of Groningen

Periprocedural management of abnormal coagulation parameters and thrombocytopenia in patients with cirrhosis:Guidance from the SSC of the ISTH

Prolonged prothrombin time and thrombocytopenia are common in patients with cirrhosis. These parameters do not reflect the overall hemostatic rebalance or bleeding risk in the periprocedural setting; however, attempts to correct these parameters remain frequent. We review the literature on periprocedural bleeding risk, bleeding risk factors, and the risk and benefits of hemostatic interventions in patients with cirrhosis. We provide guidance recommendations on evaluating bleeding risk in this patient group and management of hemostatic abnormalities in the periprocedural setting.</p

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   University of Groningen“Periprocedural management of abnormal coagulation parameters and thrombocytopenia inpatients with cirrhosis: Guidance from the SSC of the ISTH”Roberts, Lara N.; Lisman, Ton; Stanworth, Simon; Hernandez-Gea, Virginia; Magnusson,Maria; Tripodi, Armando; Thachil, JeckoPublished in:Journal of Thrombosis and HaemostasisDOI:10.1111/jth.15859IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2022Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Roberts, L. N., Lisman, T., Stanworth, S., Hernandez-Gea, V., Magnusson, M., Tripodi, A., & Thachil, J.(2022). “Periprocedural management of abnormal coagulation parameters and thrombocytopenia inpatients with cirrhosis: Guidance from the SSC of the ISTH”: Reply. Journal of Thrombosis andHaemostasis, 20(11), 2713-2714. https://doi.org/10.1111/jth.15859CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license.More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne-amendment.Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.    | 2713LETTERS TO THE EDITORReceived: 19 August 2022  | Accepted: 22 August 2022DOI: 10.1111/jth.15859  “Periprocedural management of abnormal coagulation parameters and thrombocytopenia in patients with cirrhosis: Guidance from the SSC of the ISTH”: ReplyWe thank Hartmann and colleagues for their interest in this guidance document and for highlighting their further work with viscoelastic testing (VET) in patients with cirrhosis.1 We agree the data presented suggest significant reductions in plasma and platelet transfusion for this patient group compared with inap-propriate use of conventional hemostatic parameters to guide prophylactic blood component transfusion. However, it is im-portant to acknowledge the limitations of VET in the evaluation of hemostasis in patients with cirrhosis. In particular, VET is in-sensitive to both protein C and von Willebrand factor (VWF), and therefore is unable to measure the ‘rebalancing’ effect of reduced protein C on reduced procoagulants or increased VWF on thrombocytopenia.2Hartmann and colleagues suggest that multiple randomized con-trolled trials in patients with cirrhosis and gastrointestinal bleeding or undergoing liver transplantation, along with meta- analyses of five to seven studies involving 300 patients provide ‘high quality’ evidence supporting the use of VET to reduce transfusion require-ments.1 We contest this assertion and maintain there is currently low quality evidence for VET to guide transfusion in the periproce-dural setting due to the limitations of the included studies. These limitations include the use of unvalidated thresholds for transfusion with VET, variable inclusion of low risk procedures, variable defini-tion of the standard of care comparator, the lack of a ‘no interven-tion’ arm in all but one of these studies,3 and most significantly, the lack of clinical endpoints along with only two of the seven studies considered as low risk of bias.4A large observational cohort of 700 patients with cirrhosis un-dergoing liver transplantation demonstrates major surgery can be safely performed without transfusion to correct abnormal hemo-static parameters,5 and published guidance supports this approach in the perioperative setting.6 The single study evaluating a restric-tive transfusion strategy in comparison to transfusion guided by VET or standard laboratory tests was performed in patients under-going central venous catheterization (a low bleeding risk procedure). Whilst this study was underpowered to evaluate clinical outcomes (with no major bleeding events), it clearly demonstrates a restrictive approach is most effective in reducing blood component transfu-sion (OR 0.09, 95% CI 0.01 to 0.56 compared with the VET- guided arm), with superior cost effectiveness.3 As the majority of proce-dures performed in patients with cirrhosis have a low bleeding risk, the routine use of VET will result in significant unnecessary blood component transfusion. Indeed, in the aforementioned study, 43% of participants received plasma in the VET- guided arm. Additionally, the larger of the two liver transplantation studies cited by Hartmann and colleagues reported a significant increase in the use of fibrinogen replacement (73% vs. 29%) with a VET- guided transfusion strategy.7 Observational studies have also noted increased cryoprecipitate use with VET in liver transplantation, with a corresponding associated increase in thrombotic complications.8 Importantly, a large retro-spective study on cryoprecipitate use in patients who are critically ill with cirrhosis demonstrated no benefit on bleeding or mortality.9 Furthermore, whilst the two RCTs in patients undergoing endoscopy of gastrointestinal bleeding demonstrated reduced use of plasma with VET, this is a low- risk procedure where centers adopting an evidence- based approach would not offer periprocedural plasma, particularly in view of the association between plasma transfusion and further increases in portal venous pressure. Recently updated EASL guidance and Baveno consensus recommended against the use of plasma in this setting due to the potential for fluid overload and worsened portal hypertension.10,11 Hence we support the re-search recommendations proposed by these bodies for large pro-spective observational studies to clearly document the incidence of periprocedural bleeding, and for randomized controlled trials in high bleeding risk procedures to evaluate the impact of interventions (in-cluding VET) on clinically important outcomes such as bleeding and mortality, incorporating a restrictive transfusion strategy in which prophylactic transfusions are avoided and blood products are only administered when bleeding occurs as a comparator. Supporting the use of VET without such evidence risks continued unnecessary blood component use, with potential patient harm, and further per-petuates the dogma of abnormal hemostatic markers reflecting a bleeding tendency in patients with cirrhosis, rather than the severity of liver disease.Manuscript handled by: Kathleen Freson Final decision: Kathleen Freson, 22 August 2022   15387836, 2022, 11, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/jth.15859 by University Of Groningen, Wiley Online Library on [10/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License2714  |    LETTERS TO THE EDITORAUTHOR CONTRIBUTIONSLNR and TL drafted the manuscript; all other authors provided intel-lectual input for revisions of the draft and approved the final version of the manuscript.CONFLIC T OF INTERE S TWe have no conflicts of interest to report.Lara N. Roberts1Ton Lisman2Simon Stanworth3Virginia Hernandez- Gea4Maria Magnusson5Armando Tripodi6Jecko Thachil71King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital, London, UK2Surgical Research Laboratory and Section of Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands3Transfusion Medicine, NHS Blood and Transplant, Department of Haematology, Oxford University Hospitals, NHS Foundation Trust, Radcliffe Department of Medicine, University of Oxford and NIHR Oxford Biomedical Research Centre (Haematology), Oxford, UK4Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, IDIBAPS, Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN- Liver), University of Barcelona, Barcelona, Spain5Clinical Chemistry and Blood Coagulation Research, MMK, Department of Pediatrics, CLINTEC, Karolinska Institutet, Department of Hematology, Karolinska University Hospital, Stockholm, Sweden6IRCCS Ca' Granda Maggiore Hospital Foundation, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa, Milano, Italy7Department of Haematology, Manchester Royal Infirmary, Manchester, UKCorrespondenceLara N. Roberts, King's Thrombosis Centre, Department of Haematological Medicine, King's College Hospital, Denmark Hill, London SE5 9RS, UK.Email: lara.roberts@nhs.netORCIDLara N. Roberts  https://orcid.org/0000-0003-3871-8491 Ton Lisman  https://orcid.org/0000-0002-3503-7140 Simon Stanworth  https://orcid.org/0000-0002-7414-4950 Virginia Hernandez- Gea  https://orcid.org/0000-0001-7937-984X Maria Magnusson  https://orcid.org/0000-0001-5388-6608 Armando Tripodi  https://orcid.org/0000-0003-1602-2776 Jecko Thachil  https://orcid.org/0000-0001-7218-0993 T WIT TERLara N. Roberts  @LaraNRoberts1 R E FE R E N C E S 1. Hartmann J, Dias JD, Garcia- Tsao G, Pivalizza E. Periprocedural man-agement of abnormal coagulation parameters and thrombocytopenia in patients with cirrhosis: guidance from the SSC of the ISTH: com-ment from Hartmann et al. J Thromb Haemost. 2022;20(1):39- 47. 2. Lisman T, Hernandez- Gea V, Magnusson M, et al. The concept of re-balanced hemostasis in patients with liver disease: communication from the ISTH SSC working group on hemostatic management of pa-tients with liver disease. J Thromb Haemost. 2021;19(4):1116- 1122. 3. Rocha LL, Neto AS, Pessoa CMS, et al. Comparison of three trans-fusion protocols prior to central venous catheterization in patients with cirrhosis: a randomized controlled trial. J Thromb Haemost. 2019;18(3):560- 570. 4. Tangcheewinsirikul N, Moonla C, Uaprasert N, Pittayanon R, Rojnuckarin P. Viscoelastometric versus standard coagulation tests to guide periprocedural transfusion in adults with cirrhosis: a meta- analysis of randomized controlled trials. Vox Sang. 2022;117(4):553- 561. 5. Massicotte L, Thibeault L, Roy A. Classical notions of coagula-tion revisited in relation with blood losses, transfusion rate for 700 consecutive liver transplantations. Semin Thromb Hemost. 2015;41(5):538- 546. 6. Biancofiore G, Blasi A, de Boer MT, et al. Perioperative hemo-static management in the cirrhotic patient: a position paper on be-half of the liver intensive care group of Europe (LICAGE). Minerva Anestesiol. 2019;85(7):782- 798. 7. Bonnet A, Gilquin N, Steer N, et al. The use of a thromboelastometry- based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: a randomised controlled study. Eur J Anaesthesiol. 2019;36(11):825- 833. 8. Nguyen- Buckley C, Gao W, Agopian V, Wray C, Steadman RH, Xia VW. Major thromboembolic complications in liver transplantation: the role of rotational thromboelastometry and cryoprecipitate transfusion. Transplantation. 2021;105:1771- 1777. 9. Budnick I, Davis J, Sundararaghavan A, et al. Transfusion with cryo-precipitate for very low fibrinogen levels does not affect bleed-ing or survival in critically ill cirrhosis patients. Thromb Haemost. 2021;121:1317- 1325. 10. de Franchis R, Bosch J, Garcia- Tsao G, Reiberger T, Ripoll C. Baveno VII– renewing consensus in portal hypertension. J Hepatol. 2022;76(4):959- 974. 11. Villa E, Bianchini M, Blasi A, et al. EASL clinical practice guidelines on prevention and management of bleeding and thrombosis in pa-tients with cirrhosis. J Hepatol. 2022;76:1151- 1184. 15387836, 2022, 11, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/jth.15859 by University Of Groningen, Wiley Online Library on [10/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

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Periprocedural management of abnormal coagulation parameters and thrombocytopenia in patients with cirrhosis:Guidance from the SSC of the ISTH

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