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Critical Care and Resuscitation BRIEF REPORTS FROM THE ASM OF THE JFICM Elective fresh frozen plasma in the critically ill: what is the evidence? Santosh G Verghese Fresh frozen plasma (FFP) is human donor plasma, either ABSTRACT recovered from a single whole blood donation or obtained by plasmapheresis. It is frozen within 8 hours of collection The scientific rationale for administering fresh frozen from a donor and typically stored at – 30° C. When appro- plasma (FFP) rests on the assumptions that patients are at priately stored, FFP is usable for a year from the date of risk of adverse effects from inadequate coagulation factors, collection. Standard FFP units derived from a single unit of and that FFP transfusions can decrease those risks. whole blood have a volume of about 300 mL. After thaw- There is a general but unfounded enthusiasm for FFP use ing, FFP contains near normal levels of many plasma across a range of clinical specialties in hospital practice. proteins, including procoagulant and inhibitory compo- Plasma for transfusion is most often used when a patient nents of the coagulation cascades and albumin. The hae- has abnormal results on coagulation screening tests, either mostatic factor content of FFP is shown in Table 1. as therapy in the face of bleeding, or in patients who are Crit Care Resusc ISSN: 1441-2772 1 Septem- not bleeding as prophylaxis before invasive procedures or ber 2008 10 3 264-268 surgery. Evidence©Crit for andCare against Resusc effectiveness 2008 www.jficm.anzca.edu.au/aaccm/journal/publi- Laboratory abnormalities of coagulation are considered by The cations.htmscientific rationale for administering FFP rests on the many clinicians to help predict bleeding before invasive Brief Reports from the ASM of the JFICM assumptions that: procedures where bleeding risk exists; FFP is presumed to • Patients are at risk of adverse effects from inadequate improve the laboratory results and reduce this risk. levels of coagulation factors; and However, most guideline indications for the prophylactic • FFP transfusions can decrease those risks. use of FFP are not supported by evidence from good-quality The clearest evidence for a direct beneficial effect of FFP randomised trials. In fact, the strongest randomised would be expected from randomised controlled studies of controlled trial evidence indicates that prophylactic plasma FFP compared with no FFP. Studies comparing FFP with non- for transfusion is not effective across a range of clinical blood products (eg, solutions of colloids or crystalloids) settings. This is supported by data from non-randomised might also assess effectiveness, but would need to be studies in patients with mild–moderate abnormalities in separately evaluated, given that these solutions have differ- coagulation tests. ent in-vivo and in-vitro effects on coagulation themselves. It is also crucial to clearly understand the risks associated Of a total of 57 published randomised controlled trials on with use of FFP, as no studies have taken adequate account the use of FFP identified in a systematic review, only 17 of the extent to which adverse effects might negate the compared FFP with no FFP or a colloid/crystalloid solution in clinical benefits of treatment with FFP. adults. When all randomised controlled trials evaluating New trials are needed to evaluate the efficacy and adverse prophylactic FFP use across a range of settings (including effects of plasma, both in bleeding and non-bleeding cardiac, neonatal, and other clinical conditions) were con- patients, and to determine whether presumed benefits sidered, the results failed to show evidence for the effec- outweigh the real risks. In addition, new haemostatic tests tiveness of prophylactic FFP for a range of clinical and that better define the risk of bleeding and monitor the laboratory outcomes.1 Two large well-conducted trials, effectiveness of FFP use should be validated. designed to evaluate the effectiveness of FFP (one in neonates, and the other in patients with acute pancreatitis), Crit Care Resusc 2008; 10: 264–268 found a lack of benefit from the prophylactic use of FFP.2,3 Coagulation screening tests and clinical bleeding. The international normalised ratio (INR) is based coagulopathy on PT and was developed to monitor warfarin therapy by The commonly used tests of coagulation, such as pro- standardising results to account for different sensitivities of thrombin time (PT) and activated partial thromboplastin thromboplastins. It has been argued that the extrapolation time (APTT), have been found to be poor predictors of of PT to INR is valid only for patients stably anticoagulated 264 Critical Care and Resuscitation • Volume 10 Number 3 • September 2008 BRIEF REPORTS FROM THE ASM OF THE JFICM with vitamin K antagonists, and may least 20%–30% of normal, and fibrin- not be valid for patients with, for exam- Table 1. Typical factor ogen levels are greater than 0.75 g/L.4 ple, liver disease.4 concentrations in a freshly Coagulopathy after trauma is common In a systematic review, Segal and Dzik thawed unit of fresh frozen but is usually attributed to dilution addressed the problems of relating the plasma (300 mL) from intravenous fluid therapy and standard in-vitro tests to in-vivo haemos- massive blood transfusion, progressive tasis by asking whether abnormalities in Concentration hypothermia, and acidosis. Evidence Factor (IU/mL)* coagulation tests correlate with an that coagulation factors can be Factor II 80 increased risk of clinical bleeding. They depleted sufficiently to produce bleed- Factor V 80 concluded that the published studies did ing due to dilutional coagulopathy Factor VII 90 not provide evidence for a predictive alone is limited. Replacement of an Factor VIII 92 5 value of PT or INR for bleeding. In Factor IX 100 entire blood volume leaves the patient patients undergoing invasive procedures Factor X 85 with about a third of the original con- who have no history of bleeding, retro- Factor XI 100 centration of coagulation factors. spective studies show that abnormal PT Factor XII 83 Additional factors may play an and APTT are poor predictors of bleed- Factor XIII 100 important role in the development of ing.6,7 Given the understanding that Antithrombin III 100 coagulopathy. Recently published stud- overall haemostasis depends on a com- Von Willebrand factor 80 ies showed that a clinically important plex interrelationship between endothe- Fibrinogen (g/L) 2.67 acute coagulopathy exists after lium, platelets, other inflammatory cells, * Unless otherwise specified. trauma, before and independent of fibrinolysis and inhibitors, as well as pro- that caused by fluid replacement ther- coagulant factors, it is not surprising that apy, hypothermia and acidosis.9 The an abnormality in one component of the coagulation cas- release of mediators after tissue trauma activates multiple cade is not a sensitive marker of clinical haemostasis. How- humoral systems, including the coagulation, fibrinolysis, ever, laboratory tests to monitor global haemostasis are not complement, and kallikrein cascades, which contribute to readily available at present, and whether newer tests (eg, the systemic inflammatory response syndrome and multiple thromboelastogram and thrombin generation tests) can bet- organ dysfunction. The development of an acute coagu- ter predict clinical bleeding risk is unclear. lopathy may therefore be an indicator of loss of regulation The series of enzymatic reactions of the coagulation of the local inflammatory response.10 Certain injuries in cascade are strongly inhibited by hypothermia, as demon- particular are known to interfere with the coagulation strated by the dramatic prolongation of PT and APTT in system, including brain injuries,11 due to release of brain patients with this condition when all factor levels were tissue thromboplastins, and long bone fractures.12 Shock, known to be normal. Unless specifically considered, the independent of blood loss, may be associated with a contribution of hypothermia to the haemorrhagic diathesis consumptive coagulopathy, leading to microvascular bleed- may be overlooked, as coagulation testing is performed at ing.13 37° C, rather than at the patient’s actual in-vivo temperature. Few trials have evaluated the effects of therapeutic FFP Although PT and APTT may be abnormal, clinical coagu- in patients with bleeding and deficiencies of multiple lopathy does not usually occur until replacement exceeds coagulation factors, as in disseminated intravascular coag- one blood volume (10 units of packed red cells in a 70 kg ulation or massive transfusion — presumably in part man), or when the PT and APTT exceed 1.5–1.8 times because of the difficulty of designing trials in these control values.8 settings. Almost all the data to determine whether FFP administration improves clinical outcome in massive Common indications for FFP haemorrhage comes from simple mathematical models of Clinical groups in whom FFP administration is commonly washout of coagulation factors,14 and controlled and indicated include patients with major blood loss, warfarin uncontrolled observational studies. Using these data, vari- therapy, deficiencies of coagulation factors, therapeutic ous colleges have created expert recommendations. How- apheresis and thrombotic thrombocytopenic purpura and ever, these mathematical models are criticised as they cardiac surgery. assume a stable blood volume and calculate the exponen- tial decay of each blood component when bleeding and Massive haemorrhage replacement rates are constant and
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