13. Plasma and Clotting Factors in Adults and Pediatrics

What is plasma? 

Plasma for transfusion can originate from whole blood centrifugation or an apheresis procedure called plasmapheresis. It is subsequently frozen and stored to be used as plasma for clinical transfusion or sent for further fractionation to produce purified protein concentrates, including coagulation factors, immunoglobulins (normal or specific, e.g., Rh (D) immune globulin), anticoagulants (e.g., antithrombin, protein C), complement-related proteins (C1-esterase inhibitor), and albumin. After thawing for transfusion, frozen fresh plasma (FFP) contains near-normal levels of most plasma proteins, including the procoagulant and inhibitory components of the coagulation system. It also contains a citrate anticoagulant solution, which remains after the collection procedure to prevent clotting during storage.

Factor VIII is typically the only plasma protein whose level is quality-controlled for the specification of the product by the European Directorate for the Quality of Medicines and HealthCare (EDQM) guidelines,¹ and this threshold needs to be met for only a proportion of units (typically 75%). This is not because of the required amount of Factor VIII for plasma transfusion efficacy but rather as a quality indicator of the process from collection to freezing and storage. Coagulation factor content is maintained in thawed FFP for up to 5 days but with evidence of a decrease in the labile clotting factors V and VIII.  A typical unit of plasma derived from a collection of whole blood has a volume of just under 300 ml, and local and national guidelines for usage generally specify a therapeutic dose of around 10 - 20 ml/kg.  Different plasma preparations are available. ²

What are the Risks of Plasma?

The administration of plasma preparations is not without risk; it may be amongst the highest risk of all blood components. More immediate and serious complications of plasma are transfusion-related acute lung injury (TRALI) and transfusion-related circulatory overload (TACO). Over the years, the association between cases of TRALI and female donors highlighted by reports of most hemovigilance systems has led to the use of predominantly male donors for plasma preparations, and the incidence of TRALI has decreased.

Fluid overload may be a more significant issue if larger plasma doses are transfused to attempt a complete reversal of abnormal coagulation tests. The risks related to TACO are poorly understood but could be crucial for critically ill patients, for example, in intensive care units (ICUs). Other risks are RTTIs. Allergic reactions to plasma are relatively common, with a frequency of around 1-3% of all transfusions, and can result in morbidity or, rarely, life-threatening conditions for some multi-transfused patients. The most serious of the allergic reactions is severe anaphylaxis, which may develop in IgA-deficient patients with IgA antibodies. A febrile nonhemolytic transfusion reaction (FNHTR) is a febrile response caused by cytokines released from blood donor leukocytes by incompatible donor antibodies recognizing recipient antigens as foreign or mediated by bioactive mediators released by the remaining leukocytes during the freeze-thaw process. Almost universal leukoreduction has decreased the rates of FNHTR in recent years. Understanding the risks of plasma transfusion is essential when considering its use as prophylaxis, which represents a common indication in clinical practice. A prophylactic policy should only be justified if the risk of bleeding exceeds the risk of adverse events.

Rates of Selected Transfusion Reactions with FFP^8,9

Adults

What Do the Guidelines Say About the Use of Plasma?

Plasma for transfusion has two clinical indications: prophylaxis and therapeutic use. It is often given as prophylaxis due to abnormal coagulation screening tests before surgery or procedures or for therapeutic measures in bleeding patients.

Prophylactic Use of Plasma

It has been estimated that 24%–48% of plasma requests were for patients scheduled for invasive procedures.¹⁰ Clinicians often use abnormal coagulation parameters to guide plasma transfusion before surgery or invasive procedures. The underlying assumptions guiding this practice are as follows: prolonged coagulation parameters, such as prothrombin time (PT)/international normalized ratio (INR), correlate with bleeding risks; transfusion of plasma can correct abnormal PT/INR and reduce risks of bleeding; and prophylactic plasma transfusion results in less bleeding.¹¹ However, the standard coagulation parameters might not be the best method to guide plasma transfusion due to six limitations that are outlined below.

Limitations of Using Coagulation Tests as Indicators12

Unfortunately, quality evidence does not support the practice of giving prophylactic plasma. Several systematic reviews have concluded that an abnormal PT or INR does not predict bleeding risk in patients undergoing procedures.¹⁰A pilot randomized controlled trial found no differences in hemoglobin levels in two groups of patients undergoing invasive procedures treated with plasma compared to those who received no treatment.¹⁰

Key Points from International Society Guidelines

British Society of Haematology (BSH) (2018)⁵

Abnormal coagulation tests are poor predictors of bleeding in non-bleeding patients prior to invasive procedures. A thorough clinical assessment should be conducted, considering factors such as bleeding history, family history, and medications. Coagulation tests are important for moderate-to-high-risk patients, such as those on anticoagulants or with a positive bleeding history. Plasma’s impact in correcting coagulation parameters is minimal when the PT/INR is mildly prolonged (1.5–1.9).

Association for the Advancement of Blood and Biotherapies (AABB):¹³

The AABB does not recommend for or against using plasma in non-bleeding patients undergoing invasive procedures, citing insufficient clinical data.

National Blood Authority (NBA-Australia):¹⁴

Prophylactic use of plasma is not recommended in cardiac surgery and for medical patients with a coagulopathy. Coagulation tests, particularly the INR, correlate poorly with bleeding risk in liver disease. Patients with an INR of ≤2 can often undergo invasive procedures without significant bleeding risk and generally do not benefit from plasma.

Summary of Recommendations from Different Countries

 

Therapeutic Use of Plasma¹⁵

Replacement of Isolated/Single Factor Deficiencies

Plasma is indicated for replacing isolated factor deficiencies (II, V, VII, IX, X, and XI) and where specific factor concentrates are unavailable. Plasma transfusion may increase the concentration of one factor above 0.5 U/mL. 

Thrombotic Thrombocytopenic Purpura (TTP)

Most patients with TTP have normal or nearly normal coagulation tests. In some cases, late findings may resemble those seen in disseminated intravascular coagulation (DIC), such as low platelet count, abnormal PT, and aPTT. Neurological abnormalities typically appear later and signal significant deterioration that requires immediate intervention. Most TTP patients lack an active metalloproteinase enzyme, leading to ultralarge von Willebrand factor multimers buildup, which causes excessive platelet activation and consumption. The primary treatment for acute TTP is daily plasma exchange. Single-volume daily plasma exchange should be performed at presentation. Daily plasma exchange should continue for a minimum of two days after remission is achieved.

Liver disease

Patients with liver disease often have various coagulation abnormalities by different mechanisms, which correlate with the extent of liver damage. The hemostatic abnormalities include reduced coagulation factor synthesis (evident by a prolonged PT), increased fibrinolysis, and thrombocytopenia. A risk of excessive bleeding typically occurs in gastrointestinal bleeding, e.g., variceal rupture, bleeding during routine procedures (liver biopsy), and during major surgery. Plasma transfusion is recommended in the situation of actual bleeding or preparation for surgery or a liver biopsy if the PT/INR are moderately prolonged (> 2.0). The response to plasma in liver disease is unpredictable. Coagulation tests should be repeated immediately after the infusion if plasma is administered to guide future transfusion decisions.

Massive Hemorrhage

Massive blood transfusion is defined as replacing a patient's total blood volume with stored blood in under 24 hours. Other definitions include 50% blood volume loss within 3 hours or 150 ml/minute bleeding rate. Plasma is not effective in controlling bleeding from surgically correctable issues or if underlying conditions contributing to coagulopathy are not treated, such as hypothermia, vascular hypertension, ionized hypocalcemia, acidosis, and anemia. 

Plasma should be administered if microvascular bleeding is associated with significantly increased PT, INR, or aPTT, representing a "double threshold" indicating coagulopathy. Prolongation of PT and aPTT (>1.8 times the normal) indicate a significant decrease in coagulation factors.

Disseminated Intravascular Coagulation

Plasma is indicated for patients with multi-factor deficiencies associated with severe bleeding or DIC. DIC occurs secondary to septicemia, massive blood loss, severe vessel injury, or toxins (e.g., snake venom, amniotic fluid, and pancreatic enzymes), which trigger the coagulation pathway. Decompensated DIC may result in overt microvascular bleeding or microangiopathic thrombosis. Coagulation factors will be reduced, especially fibrinogen, FV, FVIII, and FXIII. 

The primary approach to managing DIC is treating the underlying cause. While transfusion support may be necessary, there is no agreement on the best treatment. When the patient is bleeding, a combination of plasma, platelets, and cryoprecipitate is recommended. However, if there is no bleeding, blood products should not be administered, regardless of laboratory test results, and there is no evidence supporting the use of platelets or plasma for prophylaxis. 

Reversal of effects Vitamin K antagonist -Vitamin K vs. prothrombin complex concentrate (PCCs) vs. plasma¹⁶

Vitamin K antagonists (VKA) are mainly employed to prevent and treat thrombotic disorders. The response to VKAs is variable considering their specific interaction with the vitamin K cycle, and hence interference with hepatic synthesis of vitamin K-dependent coagulation factors. Monitoring the anticoagulant effect of VKAs by assessing the INR is essential, considering that complications are closely related to the intensity of anticoagulation. Reversal of VKAs could be required in case of bleeding or before high-risk surgery or interventions. The choice of methods to reverse VKAs depends on whether the patient is bleeding or needs an urgent procedure and should be based on the pharmacokinetic and pharmacodynamic properties of the VKA. Reversal strategies include the administration of vitamin K1 and substitution of vitamin K-dependent procoagulant factors prothrombin complex concentrate (PCCs) vs. plasma. In patients with substantially elevated INRs (above 5), supplementation of vitamin K1 leads to a more rapid decline of the INR than just withholding VKAs. Depending on the clinical situation, vitamin K1 may be given as oral or intravenous (IV) preparation.

Low doses of vitamin K1 are given orally to non-bleeding patients with INR values > 4.5, which lowers the INR to levels between 1.8 and 4.0.  Response to vitamin K1 is faster after IV than oral application, albeit with similar INR levels after 24 hours.  PCCs are purified concentrates of vitamin K-dependent coagulation factors and are available in a non-activated and an activated form. Non-activated 4-factor concentrates, which contain all vitamin K-dependent procoagulant factors (FII, FVII, FIX, and FX), can be considered as the preparations of choice for vitamin K reversal¹⁷  Patients receiving 4F-PCC had a more significant reduction in INR when compared to 3F-PCC. However, both types of products have been used in anticoagulation reversal, and this does not seem associated with a decrease in the length of stay or mortality¹⁸ or a worse outcome.19 Efficacy of plasma for VKA reversal has not been systematically established. Coagulation factor content in plasma preparations is variable. The minimum coagulation factor level for sufficient hemostasis is approximately 30%, but the relative contribution of individual clotting factors is unknown. The minimum amount of plasma for effective restoration of hemostasis is 10-20 mL/kg body weight. Considering the short half-lives of some coagulation factors, particularly FVII, repeat transfusions are often necessary to maintain the required coagulation factor levels. As a result, compared to plasma, using PCC for warfarin reversal is associated with significantly reducing all-cause mortality, more rapid INR decrease, and less volume overload.20

Plasma to Reconstitute Whole Blood (for Circuits or Neonatal Exchange Transfusions).

Plasma is also used to reconstitute whole blood to prime cardiothoracic surgery, extracorporeal membrane oxygenation (ECMO) circuits, or neonatal exchange transfusion.21,22 Neonatal exchange transfusion is a procedure mainly employed in cases of hemolytic disease of the fetus and newborn (HDFN), characterized by red cell alloantibodies leading to neonatal hemolysis or severe anemia. The use of this procedure has, over the years, expanded to hyperbilirubinemia induced by neonatal sepsis, DIC, metabolic disorders (such as aminoaciduria with associated hyperammonemia), severe fluid or electrolyte imbalances, and polycythemia.

The exchange of large volumes of plasma and their replacement with colloids and allogeneic plasma represents a potentially curative option for severely ill patients. Plasma exchange has been used to treat various neurology, hematology, and rheumatology pathologies. The American Society for Apheresis (ASFA) periodically reviews and updates the indications for plasmapheresis and plasma exchange according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria.23

Pediatrics

Plasma is used to replace coagulation factors in preterm and full-term infants experiencing hemorrhage or prior to surgery, especially if multiple factor deficiencies are a concern, such as hemorrhagic disease of the newborn due to vitamin K deficiency.²⁴ The indications for plasma transfusion are similar in neonates and pediatric patients.

Transfusion Guidelines for Plasma Components in Neonates and Older Children^24–28

FFP,  thawed plasma, and FP24 are all acceptable for neonates and pediatric patients.²⁴ The usual dose is 10 to 20 mL/kg, which is expected to increase all activity levels by 15% to 20% unless there is a marked consumptive coagulopathy.²⁹ It should be noted that the evidence supporting the use of plasma to correct coagulopathy with bleeding or to correct an INR <1.5 is weak.^30–33A prospective observational study showed that plasma transfusions were independently associated with an increased risk of new or progressive multiple-organ dysfunction, nosocomial infections, and prolonged length of stay in 831 children admitted to one institution’s pediatric critical care unit. This indicates that plasma should be used judiciously, and its utilization should be closely monitored in a pediatric PBM program.²⁸

Blood can be collected into a system with multiple, integrally attached bags that create ready-to-freeze aliquots, limiting exposure to each recipient while minimizing plasma waste.³⁴ Some institutions use AB plasma because a single unit can provide multiple small-volume doses for several neonates. As only a small percentage of the population is AB, the supply can be challenging to maintain.

In some countries, SD plasma is an increasingly used plasma product. A recent study showed decreased mortality in children in the intensive care unit who received SD plasma compared to those who received FFP or FP24.³⁴The filtration process to remove cellular debris and the dilution of individual donor plasma proteins may reduce the risk of allergic reactions and TRALI.²⁴

How should we monitor and assess the efficacy of plasma transfusion?

Clinical conditions and standard laboratory tests should be used to assess and monitor the need and efficacy of plasma transfusion. However, there is evidence of substantial deviation from the recommended practice.³⁵  In emergencies, point-of-care viscoelastic testing (VET) offers real-time rapid assessment of hemostasis. It has the advantages of a faster turnaround time and global evaluation of hemostatic function compared with conventional coagulation tests. Therefore, it is a valuable tool for guiding diagnosis and decisions regarding blood component transfusions in complex coagulopathies, which characterize clinical settings such as liver transplantation, cardiothoracic surgery, and trauma.36 Successful implementation of VET and its application in different clinical settings significantly reduced red blood cell, platelet, and FFP transfusion,  decreasing transfusion costs and blood component wastage ³⁷ with a net cost-saving effect.

Monitoring Plasma Appropriate Use

This is of paramount importance. This is commonly regarded as a responsibility of the Hospital Committee for appropriate blood utilization, and it implies the following:

Audits

Clinical audits are the most widely used tool for the evaluation of the proper use of scarce resources, including plasma. Clinical auditing is a process that can be defined as a quality improvement process that seeks to improve patient care and outcomes through a systematic review of care against explicit criteria and the implementation of change when needed.³⁸ Transfusion audits are required by most accreditation programs and are also recommended by the World Health Organization. The key component of a clinical audit is that performance is reviewed to ensure that what should be done has been accomplished, and if not, it provides a framework to enable improvements to be made.  The results of a recent survey organized by the International Society for Blood Transfusion (ISBT) indicate that there are national and or local guidelines for plasma transfusion in at least 85% (adults) and 76% (pediatrics) of 172 responding centers (mainly Europeans) but only 40% regularly audit plasma transfusion against these guidelines. Moreover, there is evidence that, wherever performed worldwide, audits on the use of plasma demonstrate an impressive lack of appropriateness in plasma transfusion. A manual for optimal blood use has been published by the  “European Optimal Use of Blood” project³⁹ (a program on the optimal use of blood resources funded by the European Union). It offers guidance and resources to begin the development of a quality system for the clinical transfusion process. The manual contains a section on clinical audits applicable to plasma products.

References

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The authors

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