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Fresh Frozen Plasma (FFP)
Indications
Fresh frozen plasma (FFP) transfusion is indicated for patients with coagulation factor deficiencies who have abnormal coagulation test results and active bleeding. Additional indications include planned surgery or invasive procedures when coagulation tests are abnormal, warfarin reversal in active bleeding, and planned procedures when vitamin K is insufficient to counteract warfarin effects. Other applications include thrombotic thrombocytopenic purpura (TTP) and congenital or acquired factor deficiencies without alternative therapies.[1]
A systematic review supports FFP use in trauma requiring massive transfusion and warfarin-related intracranial hemorrhage.[2] Guidelines from the Neurocritical Care Society and the Society of Critical Care Medicine recommend that if prothrombin complex concentrates (PCCs) are unavailable or contraindicated, alternative treatments should be considered rather than withholding treatment. When PCCs are not available, FFP and vitamin K are preferred over no treatment.[3] The study does not provide clear recommendations for or against FFP transfusion at a plasma-to-red blood cell ratio of 1 to 3 or higher in patients with massive transfusion due to trauma.
Conditions that lead to multiple coagulation factor deficiencies and may require FFP include liver disease and disseminated intravascular coagulation (DIC). However, FFP transfusion may not be well tolerated in patients with liver disease due to the high infusion volumes needed to achieve adequate hemostatic levels.[4][5][6]
Venom-induced consumption coagulopathy, a complication of snake envenoming, improves more rapidly when FFP is administered after antivenom.[7] In burn patients, early FFP administration using a restrictive 2 cc/kg/% total body surface area resuscitation formula has been associated with reduced fluid requirements, improved clinical outcomes, and fewer complications, though further research is needed to confirm these findings.[8]
The 2022 American Heart Association/American Stroke Association guideline states that 4-factor PCC (4F-PCC) is more effective than FFP in rapidly reversing anticoagulation in vitamin K antagonist-associated intracerebral hemorrhage with a high international normalized ratio (INR). Administration of 4F-PCC also reduces hepatic encephalopathy, though no significant differences have been observed in long-term outcomes. FFP remains a valid treatment option, particularly when 4F-PCC is unavailable. Studies indicate that 4F-PCC corrects INR more rapidly, but its optimal dosing requires further investigation.
Vitamin K should always be administered alongside any coagulation factor replacement. While 4F-PCC provides benefits in rapid INR correction, careful dosing is necessary to minimize the risk of venous thromboembolism, particularly at higher doses.[9]
A study found that FFP played an important role in obstetrical DIC, particularly in patients with low fibrinogen levels. FFP, often combined with fibrinogen concentrate, was demonstrated to be used more frequently in patients with DIC than in those without.[10] Additionally, a randomized controlled trial evaluating FFP as an adjunctive therapy for acute organophosphorus poisoning showed that early administration significantly reduced the need for atropine and oximes, shortened hospitalization, and decreased the requirement for mechanical ventilation.[11]
Mechanism of Action
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Mechanism of Action
FFP is the fluid portion of a unit of whole blood frozen used within a designated time frame, typically within 8 hours. This liquid contains all coagulation factors except platelets and includes fibrinogen (400-900 mg/unit), albumin, protein C, protein S, antithrombin, and tissue factor pathway inhibitors. FFP is free of erythrocytes and leukocytes.
FFP corrects coagulopathy by replacing or supplying plasma proteins in patients with deficiencies or defects in these proteins. A standard dose of 10 to 20 mL/kg (4-6 units in adults) raises factor levels by approximately 20%. Increasing several factor levels by roughly 10% is generally sufficient to achieve hemostasis. Additionally, FFP provides some volume resuscitation, as each unit contains approximately 250 mL.[12][13][14][15]
FFP administration is a critical therapeutic modality for patients with coagulopathies, providing a broad range of coagulation factors, proteins, albumin, and immunoglobulins. The treatment's mechanism of action involves replenishing deficient coagulation factors, including fibrinogen, prothrombin, and factors V, VII, IX, and X. This restoration of the coagulation cascade promotes thrombus formation and ensures effective hemostasis. In conditions such as liver disease, DIC, and acquired coagulopathies, FFP helps reestablish endothelial function by supplying fibrinolytic proteins and correcting imbalances in coagulation and fibrinolysis.
In TTP, FFP replaces the von Willebrand factor-cleaving protease (ADAMTS13), which is essential for preventing the formation of microvascular platelet-rich thrombi. However, FFP transfusion carries risks, including transfusion-related acute lung injury (TRALI), which can result from antibodies formed during prior transfusions or pregnancies. Additionally, the large volumes required for certain indications may contribute to complications such as volume overload or cardiogenic pulmonary edema. Therefore, while FFP is indispensable in specific therapeutic scenarios, its administration requires careful consideration of both its benefits and potential complications.[16]
Administration
Available Dosage Forms and Strengths
Pooled human plasma (human plasma protein) solution is available in concentrations ranging from 45 to 70 mg/mL. FFP typically contains approximately 1 IU/mL of each coagulation factor, including the labile ones. FFP is administered exclusively via the intravenous route and must be ABO-compatible with the recipient’s red cells. Before administration, the FFP container and fluid should be inspected for leaks, clots, or abnormal discoloration. FFP is stored at -30 °C and thawed before use. Thawing occurs in a water bath at 30 °C to 37 °C over 20 to 30 minutes or in an FDA-cleared device in as little as 2 to 3 minutes. Once thawed, FFP should be administered immediately. Storage at 1 °C to 6 °C is required if not used right away.
Some institutions discard thawed FFP if unused within 24 hours, while others permit its use for up to 7 days.[17] Once thawed, clotting factor activity declines gradually, particularly factor V and factor VIII. Due to the short half-life of factor VII, which ranges from 2 to 6 hours, readministration may be necessary every 6 to 8 hours in cases of ongoing bleeding.
Adult Dosage
The recommended FFP dosage for managing or preventing bleeding is 10 to 20 mL/kg of body weight. Timely administration is essential for reversing anticoagulation in warfarin-related intracerebral hemorrhage, as each 30-minute delay in FFP dosing reduces the likelihood of INR correction within 24 hours. In emergency settings, minimizing delays in FFP administration should be prioritized to optimize patient outcomes.[18]
Considerations Before Fresh Frozen Plasma Administration
FFP's effectiveness is limited in patients with cirrhosis. Therefore, the treatment should be used cautiously for prophylaxis before invasive procedures in this context. FFP has minimal impact on mildly prolonged INR, and routine use before procedures is not recommended due to risks such as volume overload, worsened portal hypertension, and a paradoxical increase in bleeding risk.[19] The American Association for the Study of Liver Diseases advises against the routine prophylactic use of FFP or platelets before paracentesis.[20]
The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines recommend plasma exchange with FFP for patients experiencing alveolar hemorrhage or undergoing the immediate post-biopsy period.[21] However, studies indicate that FFP transfusion in critically ill patients with significant coagulopathy does not improve 30-day, 90-day, or in-hospital mortality. Instead, the treatment has been associated with an increased risk of kidney failure (odds ratio: 1.90, 95% CI 1.13–3.18) and a prolonged ICU and hospital stay.[22]
The International Federation of Gynecology and Obstetrics (FIGO) recommends massive transfusion protocols for severe postpartum hemorrhage that incorporate blood products, including packed red blood cells, FFP, and platelets, to mimic whole blood replacement. Additional transfusion rounds are guided by ongoing bleeding and institutional protocols.[23]
The American Academy of Pediatrics advises urgent exchange transfusion for infants with total serum bilirubin (TSB) levels at or above the exchange transfusion threshold. However, the transfusion can be deferred if the TSB drops below the threshold before the procedure begins and the infant shows no signs of advanced bilirubin encephalopathy. In such cases, intensive phototherapy should continue with regular TSB monitoring. The preferred approach to exchange transfusion involves cross-matched, washed-packed red blood cells combined with thawed adult FFP to achieve a hematocrit of approximately 40%, facilitating bilirubin removal.[24]
Premature and critically ill infants often receive FFP due to an increased bleeding risk, with up to 10% requiring transfusions. Neonates have longer clotting times than adults but do not necessarily have a higher bleeding risk. FFP should primarily be reserved for neonates with active bleeding and coagulopathy, and further research is needed to refine indications for its use in neonatal bleeding complications.[25]
Older trauma patients tend to experience more severe injuries, require more blood transfusions, and have higher mortality rates. A propensity-matched analysis reduced differences between geriatric and nongeriatric patients but still showed a lower incidence of acute trauma coagulopathy in the geriatric group. Nevertheless, clinical outcomes were worse, with higher rates of complications, rehabilitation needs, and mortality. The increased mortality may be linked to greater blood product usage and undertriage to tertiary trauma centers, which negatively affects outcomes. These findings underscore the need for improved triage and tailored care for older trauma patients, even when injuries appear less severe.[26]
Adverse Effects
The adverse effects of FFP are similar to those associated with whole blood and other blood components. Complications can be categorized as nonimmunologic, immediate immunologic, and delayed immunologic reactions. The absence of cells in FFP reduces the risk of certain disease transmissions and immune responses. Cytomegalovirus (CMV) and graft-versus-host disease are not transmitted through FFP, as viable leukocytes are absent.
Nonimmunologic complications include the transmission of infectious agents, transfusion-associated circulatory overload (TACO), and metabolic disturbances such as citrate toxicity. Infectious agents that can be transmitted through FFP include HIV and hepatitis B and C.[27] However, screening and pathogen inactivation measures have significantly reduced transmission rates, with HIV occurring in approximately 1 in 7.8 million transfusions, hepatitis B virus in 1 in 153,000, and hepatitis C virus in 1 in 2.3 million. TACO results from cardiogenic pulmonary edema and can develop when transfusion volumes are excessive or administered too rapidly.
Immediate immunologic complications include hemolytic transfusion reactions, febrile nonhemolytic reactions, allergic reactions, anaphylactoid or anaphylactic reactions, and TRALI. Hemolytic transfusion reactions occur due to anti-A and anti-B antibodies when ABO matching fails. TRALI is the most common cause of transfusion-related death, presenting as acute-onset hypoxemia and noncardiogenic pulmonary edema in the absence of other causes of acute lung injury or circulatory overload. TRALI occurs when stimuli in transfused blood components, such as donor-derived white blood cell antibodies or pro-inflammatory molecules that accumulate in stored blood products, trigger an inflammatory response. This response damages the alveolar-capillary membrane, leading to permeability pulmonary edema.
Delayed immunologic complications include alloimmunization to plasma proteins.[28] A recent study evaluated the association between plasma-inclusive resuscitation and TRALI in patients with severe burn injuries. No cases of TRALI were observed. Early plasma-inclusive resuscitation initiation did not lead to significantly higher resuscitative volumes despite greater total body surface area involvement. Further research is needed to confirm these findings.[29] Advancements in blood donor testing and pathogen inactivation for plasma and platelet units have significantly improved neonatal transfusion safety. However, transfusion-transmitted cytomegalovirus infection remains a risk for premature neonates.[30]
FFP also has drug interactions that can impact its safety and effectiveness. Concurrent use of FFP with corticosteroids can increase the risk of hypervolemia due to sodium and water retention. Simultaneous corticosteroid administration may lead to fluid overload, hypertension, and edema, particularly in patients with underlying cardiovascular or renal conditions. Antifibrinolytic agents such as tranexamic acid and aminocaproic acid help prevent clot breakdown and may be used alongside FFP to manage bleeding. However, careful monitoring is necessary to avoid excessive clot formation, which may increase the risk of thrombosis or other vascular complications. Additional interactions are discussed in the next section (see Contraindications).
Contraindications
FFP is contraindicated when coagulopathy can be more effectively corrected with more specific therapy or blood volume can be adequately replaced with alternative volume expanders. More targeted treatments that should be considered before FFP administration include vitamin K, cryoprecipitate antihemophilic factor, prothrombin complex concentrates, and specific coagulation factor concentrates, such as factor VII. FFP should not be used as a volume expander in individuals without coagulation deficiencies or active bleeding.
The treatment should not be given to reverse anticoagulation caused by heparin, direct thrombin inhibitors, or direct factor Xa inhibitors, as it does not effectively counteract the effects of these agents. Specific antidotes for direct oral anticoagulants are preferred for reversal. FFP is also contraindicated in patients with a history of hypersensitivity to plasma or plasma-derived products.[31]
Warning and Precautions
A study found that the most common reason for inappropriate FFP transfusions was bleeding in patients with an INR below 1.5, followed by cases where the INR exceeded 1.5 without active bleeding. (Shidkar et al) FFP transfusion carries a risk of portal hypertension and hypervolemia.[32] High infusion rates can lead to hypervolemia and pulmonary edema, requiring monitoring for signs of pulmonary congestion or heart failure and appropriate management. Febrile nonhemolytic and hemolytic reactions have been reported, as well as allergic reactions, including anaphylaxis.[33]
The American Gastroenterological Association advises against the routine use of blood products, including FFP and platelets, for bleeding prophylaxis in patients with stable cirrhosis undergoing procedures such as thoracentesis, paracentesis, variceal banding, endoscopic retrograde cholangiopancreatography, colonic polypectomy, and liver biopsy. This recommendation applies to patients without severe thrombocytopenia or coagulopathy. For individuals with significant coagulation abnormalities or low platelet counts, prophylactic transfusion decisions should weigh the risks and benefits, including transfusion reactions and procedure delays, in consultation with a hematologist.[34]
Monitoring
FFP therapy is monitored clinically, by assessing for signs of bleeding, and chemically, by evaluating coagulation studies and fibrinogen levels. Each FFP unit contains approximately 200 to 250 mL, while apheresis-derived units can have volumes ranging from 400 to 600 mL. The administration of a single 250 mL unit is expected to increase the fibrinogen level by 5 to 10 mg/dL. The primary therapeutic goal is the cessation of bleeding, with laboratory targets of prothrombin (PT) and activated partial thromboplastin (aPTT) times less than 1.5 times the normal value.[35][36][37]
In a massive transfusion protocol, key diagnostic tests include focused abdominal sonography for trauma (FAST), serum lactate, base deficit, PT, aPTT, fibrinogen levels, and platelet count. These tests help detect and monitor abdominal and thoracic bleeding while providing indicators of the extent of hemorrhage and shock.[38] Patients should be monitored for signs of circulatory overload to prevent complications such as TACO. A chest x-ray should be obtained if TACO or TRALI is suspected.[39]
Toxicity
Citrate toxicity can occur with FFP administration, as most citrate in whole blood products is found in FFP and platelets rather than in packed red blood cells. Citrate binds calcium, and excessive citrate can lead to hypocalcemia.[40] Signs and symptoms of hypocalcemia include hypotension, decreased pulse pressure, arrhythmias, mental status changes, and tetany.
Both TACO and TRALI cause acute respiratory distress and hypoxemia within 6 hours of transfusion, with pulmonary edema evident on chest radiographs. However, TACO is cardiogenic, resulting from fluid overload, elevated blood pressure, and tachycardia, and typically improves with diuretics. In contrast, TRALI is noncardiogenic, caused by immune-mediated lung injury, and is not associated with heart failure or circulatory overload. TRALI may also present with fever, leukopenia, and thrombocytopenia. The key distinction is that TACO involves cardiac dysfunction and responds to diuretics, while TRALI is driven by inflammation and lacks cardiogenic features.
The management of citrate toxicity involves discontinuing the infusion and administering intravenous calcium to correct hypocalcemia. For TACO, treatment includes diuresis and oxygen therapy, with mechanical ventilation required in severe cases.[41] Management of TRALI is primarily supportive and includes oxygen therapy, intubation if necessary, and careful administration of fluids and vasopressors to maintain hemodynamic stability.
Enhancing Healthcare Team Outcomes
A common misconception among healthcare workers is that FFP is free of adverse effects and complications. However, FFP carries risks similar to those of other blood products. All interprofessional healthcare team members, including clinicians, nursing staff, and pharmacists, should be familiar with the indications for FFP administration and the appropriate monitoring process.
Adverse effects associated with FFP transfusion are monitored similarly to those of other blood products. Vital signs, including temperature, pulse, respiration, and blood pressure, should be assessed before, during, and after administration. If a transfusion reaction occurs, management should be guided by the specific type of reaction. In most cases, FFP administration should be discontinued immediately. Severe reactions, such as TRALI and TACO, may require aggressive respiratory support, including mechanical ventilation.[42]
The proper administration and management of FFP require a coordinated effort from an interprofessional healthcare team. Optimal patient outcomes depend on comprehensive knowledge, effective communication, and collaboration among team members to ensure the appropriate use of FFP while minimizing adverse events.
Physicians oversee patient care by diagnosing conditions, directing treatment plans, and ensuring appropriate FFP administration. Advanced practice providers assess patients and coordinate care with specialists. Pharmacists contribute by verifying the safe administration of FFP and identifying potential drug interactions. Hematologists and critical care physicians play a crucial role in managing complications such as TACO and TRALI. Nurses are responsible for administering FFP, monitoring patient status, and providing direct care and support throughout treatment. An interprofessional approach that fosters communication among clinicians, hematologists, pharmacists, and nurses is essential for reducing adverse effects and improving patient outcomes related to FFP therapy.
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