HEMOSTASIS AND LIVER DISEASE. P.M. Mannucci. Scientific Direction, IRCCS Ca Granda Foundation Maggiore Hospital, Milan, Italy
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1 HEMOSTASIS AND LIVER DISEASE P.M. Mannucci Scientific Direction, IRCCS Ca Granda Foundation Maggiore Hospital, Milan, Italy
2 1964
3 ACQUIRED HEMOSTASIS DISORDERS: LIVER DISEASE Severe liver disease not uncommonly terminates with a severe bleeding state due to the gross deficiency of many coagulation factors In general bleeding is treated with replacement therapy From the textbook: Clinical Hematology in Medical Practice (G.C. De Gruchy) Blackwell Scientific Publications. Oxford,1964
4 2010
5
6 Progress of knowledge on hemostasis and liver disease
7 COAGULATION
8 Evidence of normal thrombin generation in cirrhosis despite abnormal conventional coagulation tests* Tripodi et al, Hepatology 2005;41: * Prothrombin and partial thromboplastin time (PT, APTT)
9 ETP (FU/min) 700 Platelet Free Plasma Controls Cirrhotics with thrombomodulin
10 PLATELET FUNCTION
11 Elevated levels of von Willebrand factor in cirrhosis support normal platelet adhesion Lisman et al, Hepatology 2006; 44: 53-61
12 Platelet adhesion, % Control plt/control plasma cirrhosis plt/cirrhosis plasma
13 FIBRINOLYSIS
14 Thrombin-activatable fibrinolysis inhibitor (TAFI) deficiency in cirrhosis is not associated with increased plasma fibrinolysis Lisman et al, Gastroenterology 2001; 121: 131
15 A GLOBAL FIBRINOLYSIS ASSAY Child
16 Hemostasis (coagulation, platelet function, fibrinolysis) is not abnormal in stable chronic liver disease when measured with global tests (reflecting the function of both activators and inhibitors hemostasis)
17 Normal situation-hemostatic balance Thrombophilia-Hypercoagulability Procoagulants Anticoagulants Anticoagulants Procoagulants Hemophilia-Hypocoagulability Liver disease-hemostatic rebalance Procoagulants Procoagulants Anticoagulants Anticoagulants Lisman et al. Blood 2010;116:
18
19 THE DEMISE OF A PARADIGM Abnormal hemostasis, reflected by abnormal laboratory tests, causes a bleeding tendency in patients with chronic liver disease
20 THERAPEUTIC IMPLICATIONS The demise of this paradigm questions the usefulness of hemostatic agents in the prevention and treatment of bleeding in patients with chronic liver disease
21 Little role for hemostatic agents in chronic liver disease
22 No agent acting on hemostasis is ever mentioned in this comprehensive narrative review written by established authorities in the field
23 A RECENT QUESTION TO ME FROM A PRACTICING CLINICIAN One question crucially important to my speciality but not addressed is how liver disease patients with exsanguinating hemorrhage (variceal bleeding) should be reversed, or if reversal is even indicated.
24 MAIN HEMOSTATIC AGENTS AND THEIR ACTION SITE IN LIVER DISEASE Platelet concentrates Fibrinogen concentrates
25 Vitamin K Fresh frozen plasma HEMOSTATIC AGENTS Prothrombin complex concentrates (PCC) Recombinant factor VIIa (rfviia) Fibrinogen concentrates Platelet transfusion Red cell transfusion Antifibrinolytic agents (tranexamic acid, aprotinin)
26 Vitamin K Fresh frozen plasma HEMOSTATIC AGENTS Prothrombin complex concentrates (PCC) Recombinant factor VIIa (rfviia) Fibrinogen concentrates Platelet transfusion Red cell transfusion Antifibrinolytic agents (tranexamic acid, aprotinin)
27 Vitamin K Fresh frozen plasma HEMOSTATIC AGENTS Prothrombin complex concentrates (PCC) Recombinant factor VIIa (rfviia) Fibrinogen concentrates Platelet transfusion Red cell transfusion Antifibrinolytic agents (tranexamic acid, aprotinin)
28 NEED OF BLOOD COMPONENTS AND SURVIVAL AFTER LIVER TRANSPLANTATION (OLT) The concept of bloodless OLT MT de Boer; Anesthesia and Analgesia 2008.
29
30 Background: PROTON TRIAL - background and aim- Blood loss still causes significant morbidity and mortality in the liver transplant patient and by reducing blood loss and transfusion requirements one can perhaps improve outcome.
31 PROTON TRIAL background and aim Aim: Is it possible to reduce blood loss and transfusion requirements in cirrhotic patients undergoing OLT by the use of a Prothrombin Complex Concentrate (Cofact)?
32 PROTON TRIAL Multicenter double blind RCT 5 participating centers: UMCG Groningen Erasmus MC Rotterdam Erasmus Hospital Brussel University Hospital Leuven HUS Helsinki
33 GOAL OF PROTON TRIAL To investigate the hemostatic efficacy and safety of Cofact (4 factor PCC) in reduction of requirements and blood loss in patients with cirrhosis undergoing liver transplantation Protocol published: BMC Surg ;13:22
34 HYPOTHESIS Cofact has important advantages compared to current transfusion protocols: Low volume: no aggravation of portal hypertension. Balanced supply of both pro- and anticoagulants.
35 Vitamin K Fresh frozen plasma HEMOSTATIC AGENTS Prothrombin complex concentrates (PCC) Recombinant factor VIIa (rfviia) Fibrinogen concentrates Platelet transfusion Red cell transfusion Antifibrinolytic agents (tranexamic acid, aprotinin)
36 Vitamin K Fresh frozen plasma HEMOSTATIC AGENTS Prothrombin complex concentrates (PCC) Recombinant factor VIIa (rfviia) Fibrinogen concentrates Platelet transfusion Red cell transfusion Antifibrinolytic agents (tranexamic acid, aprotinin)
37 Vitamin K Fresh frozen plasma HEMOSTATIC AGENTS Prothrombin complex concentrates (PCC) Recombinant factor VIIa (rfviia) Fibrinogen concentrates Platelet transfusion Red cell transfusion Antifibrinolytic agents (tranexamic acid, aprotinin)
38 Vitamin K Fresh frozen plasma HEMOSTATIC AGENTS Prothrombin complex concentrates (PCC) Recombinant factor VIIa (rfviia) Fibrinogen concentrates Platelet transfusion Red cell transfusion Antifibrinolytic agents (tranexamic acid, aprotinin)
39 Vitamin K Fresh frozen plasma HEMOSTATIC AGENTS Prothrombin complex concentrates (PCC) Recombinant factor VIIa (rfviia) Fibrinogen concentrates Platelet transfusion Red cell transfusion Antifibrinolytic agents (tranexamic acid, aprotinin)
40 Liver transplantation and fibrinolysis Hyperfibrinolysis by tpa release in some, but not all patients Transplantation Jun;47(6):
41 Antifibrinolytics and liver transplantation Lancet. 2000;355:1303-9
42 Percentage of Adult Liver Transplantations Without RBC Transfusion de Boer, et al. Dig Surg 2005
43 Effect of removal of aprotinin from the market Increase in blood loss after 2007?
44 The results have been confirmed by 1 group 2 other groups have not seen an increase in blood loss, but they have used other antifibrinolytic agents after the aprotinin ban.
45 Safety of aprotinin in liver transplantation
46 RECOMMENDATIONS FOR BLEEDING CONTROL IN CIRRHOSIS Limited concern for abnormal PT and APTT in the setting of cirrhosis Control any infection that is likely to impair the unstable hemostasis rebalance Control uremia to prevent platelet dysfunction Replacement with red cell transfusion: with caution to avoid deterioration of portal hypertension Consider platelet transfusion: with the goal of a platelet count of /µL Consider fibrinolysis inhibitors such as aprotinin and tranexamic acid to reduce blood loss and transfusion requirement in liver transplantation Consider the same inhibitors in the setting of active bleeding or as pre-procedural therapy
47 A. Tripodi M. Colombo, M Primignani, F. Salerno, A. Dell Era, F. Fabris M. Cazzaniga, R. de Franchis (Patient care) M. Clerici, D. Asti (Laboratory Testing) V. Chantarangkul (Supervisor & Data manager)
48
49 Liver transplantation and fibrinolysis Anhepatic phase: no synthesis, no clearance Reperfusion: tpa release from damaged endothelium
50 Primary: RBC transfusion requirements during transplantation and the 1st post-operative day Secondary: Transfusion other products Estimated blood loss Safety: ENDPOINTS Thromboembolic complications
51 Antifibrinolytics and liver transplantation Lancet. 2000;355:1303-9
52 Multivariable analysis for blood loss ( ) Odds ratio Confidence Interval P-value Aprotinin 0,40 0,23-0,71 0,002 Recipient age 1,04 1,02-1,06 <0,001 Female recipient 2,11 1,21-3,66 0,008 MELD score 1,10 1,06-1,14 <0,001
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