In January of 2019, our institution adopted guidelines for the use of Kcentra in adults with liver failure, with strict indications of major/life threatening hemorrhage or need for emergent surgery/procedure and inadequate response to blood products or inability to tolerate volume from FFP administration; dosing recommendation was for a one time dose of 25IU/kg. Each patient experienced an improvement in international normalized ratio (INR) and at least a period of clinical hemostasis after Kcentra administration without complications referable to Kcentra. Pretreatment INR: 4 to 6: Administer 35 units/kg; maximum dose: 3,500 units. If any of these therapies are warranted please contact the pharmD on call for indication, dosing, and administration assistance (pager # 7400). Each dose of KCentra (4-factor PCC) will be rounded to the nearest vial size c. The KCentra dosing and administration information is in Appendix B ... At UNCMC, Andexxa® is formulary restricted for life-threatening bleeding due to intracranial hemorrhage while on apixaban or rivaroxban with approval by the Neurocritical Care Attending. intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal, intra-articular, or pericardial) ... or rFVIIa (see PCC dosing table). Recheck INR 30 minutes after Kcentra ® dose Kcentra ® =4-Factor PCC Dose based on actual body weight up to 100 kg. Anticoagulant-associated intracranial hemorrhage. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Fixed doses ranging from 1000 IU to 1750 IU have demonstrated efficacy similar to weight-based dosing, however, few studies look exclusively at intracranial hemorrhage (ICH). 4 ml/min (210 U/min) ... REVERSAL OF COAGULOPATHY IN INTRACRANIAL HEMORRHAGE . Kcentra is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Dosing depends on current pre-dose INR (international normalized ratio) and is expressed in units of factor IX activity. EPPY = events per patient-year; GIB = gastrointestinal bleed. Dosing of phytonadione (Vitamin K) should be based on the patient’s current INR, risk of bleeding, and future need for anticoagulation (Tables 1-3). INR (baseline and at 30 Fixed dosing was associated with a greater amount of positive clinical outcomes. The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial. Dosing: Pediatric. Diagnosis: Last dose taken within 3-5 half-lives of DOAC care . Rapid triage directly to a treatment area. The Kcentra package insert recommends dosing according to the predose INR value and bodyweight as follows: 25 U/kg for INR 2 to 3.9 (max of 2500 units), 35 U/kg for INR 4 to 6 (max of 3500 units), and 50 U/kg for INR > 6 (max of 5000 units). INTRODUCTION. Denise H Rhoney. The first step in treating a post-tPA hemorrhage starts before stroke treatment: tPA should be avoided in high-risk scenarios, and each patient should be risk stratified prior to tPA infusion. Until recently, warfarin-associated ICH in the United States was typically treated … Fondaparinux (Arixtra®) Major Bleeding Reversal - Protamine ineffective – Kcentra (4-factor PCC) 50 units/kg may be of use Dabigatran (Pradaxa®) Reverse if patient shows signs of intracranial hemorrhage 1. 6. Warfarin is indicated for both treatment and prophylaxis of thromboembolic disorders, including t… The UKHealthcare aPCC on formulary is FEIBA (factor eight inhibitor bypassing activity) while the 4 factor PCC product is Kcentra. Bleeding is a major complication for any type of anticoagulant therapy and can result in a chronic debilitating condition or death. 4 Factor PCC- KCentra- 50 units/kg 3 Factor PCC FFP (when 4 Factor PCC not available) Vitamin K 5-10 mg IV Vitamin K 2.5- 10mg po *For intraparenchymal hemorrhage it is recommended to administer Vitamin K in conjunction with another reversal agent. Kcentra, Prothrombin Complex Concentrate (Human), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding. In 2013, the FDA approved Kcentra for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure. The total dose of Kcentra ordered (i.e. Kcentra Restrictions. Idarucizumab (PRAXABIND®) package insert, Boehringer Ingelheim, December 2015 5. TABLE 1. Repeat CT scans 6 and 24 hours later confirmed stable size of hemorrhage. This is EM Cases Episode 104 – Emergency Management of Intracerebral Hemorrhage – The Golden Hour with Scott Weingart and Walter Himmel.With special guest appearances by Rob Simard and Peter Brindley.. Full prescribing information traumatic intracranial hemorrhage. Dose based on actual potency as stated on the •Kcentra in U.S. & Beriplex in Europe & Canada –CLS Behring •4 factor complex concentrate –Factors II, VII, IX, X, Protein C & S •Lower risk of thrombosis? Another consideration is the increased risk of bleeding with concomitant treatment such as antiplatelet medication, non-steroidal anti-inflammatory agents and cyclooxygenase type-2 inhibitors. Doses of 1000, 1500, and 2000 units are effective for INR correction (Abdoellakhan et al., 2017; Wozniak et al., 2012; Khorsand et al., 2012; Kcentra™ Prescribing Information, 2013), however one study of patients with intracranial bleeding failed to achieve an INR of ≤ 1.5 with a fixed-dose strategy (Abdoellakhan et al., 2017). Dosing: Geriatric. Total dose: 1 mg of protamine per 100 units of heparin injected 2. The dose for the same indication may be different by brand. Refer to Table 2 below for dosing of Kcentra by indication. The Factor IX content in each vial can range from 400–620 units for … Guideline for Reversal of Antithrombotics in Intracranial Hemorrhage Oral Factor Xa Inhibitors • Stop agent • Assess exposure (last dose, renal function) Pretreatment INR ranged from 1.8 to 19.0. Dabigitran reversal is now possible with Praxbind (above). b A significant number of patients initially present with no or ... (PCC), at the direction of the treating physician (for dosing please refer to KCentra table below) Diagnosis: 1. ®Andexxa is restricted to use for intracranial hemorrhage only and must be ordered or d. Any intracranial hemorrhage on CT scan e. GCS <14 with clinical evidence of closed head injury 3. If having received IV tPA, see online Stroke Algorithm at the end of the document for IV tPA "inclusion/exclusion criteria", under “Algorithm for Treatment of Suspected Intracranial Hemorrhage after tPA” or … Single-dose Kcentra 4F-PCC—the only FDA-approved alternative to plasma for urgent warfarin reversal. Letter to The Editor in Response to The Clinical Study by Fuh et al. 1 One potential adverse effect of anticoagulation is bleeding, including intracranial hemorrhage (ICH). Inactivated Four-Factor Prothrombin Complex Concentrate Dosing Practices for Reversal of Warfarin-Related Intracranial Hemorrhage. Forty two patients who were anticoagulated with warfarin and developed intracerebral hemorrhage, subarachnoid hemorrhage or subdural hemorrhage have been treated with Kcentra since November 2013. There exists a kind of self-fulfilling prognostic pessimism when it … Intracranial hemorrhage includes intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or subdural hematoma (SDH). Refer to adult dosing. 3. a drug or other preparation that has been strengthened by evaporation of its nonactive parts. a. When using a weight-based approach, repeat dosing is not recommended. For warfarin-related intracranial hemorrhage, multiple authors describe their initial use of doses in the range of those recommended for hemophilia (up to 90 g/kg). Intracranial hemorrhage, which includes intracerebral, intraventricular, subarachnoid, subdural, and epidural bleeding, is a potentially devastating occurrence associated with anticoagulant therapy. University of North Carolina Eshelman School of Pharmacy, 115E Beard Hall, Campus Box 7574, Chapel Hill, NC, 27599-7574, USA. § 2016 Guideline for Reversal of Antithrombotics in Intracranial Hemorrhage o Strong recommendation for weight-based Kcentra dosing (mod. Warfarin is a commonly prescribed oral anticoagulant indicated for prevention and treatment of venous thromboembolism and prevention of ischemic stroke in atrial fibrillation. Administer half of the dose IV at a rate not to exceed 5 mg/min. Kcentra, Beriplex P/N [Canadian product]: Vitamin K antagonist reversal in patients with acute massive hemorrhage or in case of urgent surgery/invasive procedure: . Hemophilia B: Children and Adolescents: IV: Dosage is expressed in units of factor IX activity and must be individualized based on severity of factor IX deficiency, extent and location of bleeding, and clinical status of patient (WHF 2013). Differences in types of bleeding may be observed though, with intracranial hemorrhage lower and GI bleeding generally higher as compared to VKAs. It is notable that in this same phase IIIb study examining Kcentra, a number of exclusion criteria may be clinically relevant when considering 4F-PCC use. a. ®Andexxa is restricted to use for intracranial hemorrhage only and must be ordered or Case 37: The patient had a thrombotic event on aspirin + clopidogrel (pump thrombosis) and later had an ischemic stroke on aspirin, clopidogrel and warfarin. Depending on the antithrombotic agent and its half-life, Administration and Dosing of Kcentra For warfarin reversal in patients with an INR greater than 2 AND life-threatening bleeding related to anticoagulation > The recommended dosage of Kcentra is 25–50 units/kg of body weight (up to 100 kg), depending on the patient’s pretreatment INR value. A significant number of patients initially present with no or minimal neurological symptoms and minor intracranial hemorrhage that progress to a moribund and ultimately ... (for dosing please refer to KCentra table below) 3. The American Academy of Neurology has affirmed the value of this guideline. Their use will continue to increase in the future. Fixed dose: IV: Initial: 1,000 to 2,000 units once; for intracranial hemorrhage use, 1,500 to 2,000 units is recommended; repeat dosing has not been adequately studied and is not typically recommended unless INR reversal is inadequate. Resumption of ii. INR was normalized to 1.1 within 30 minutes and was 1.1 twenty-four hours later. Several retrospective trials have been conducted to assess the impact of antiplatelet therapy on mortality associated with intracranial hemorrhage… N=141. Note: Bebulin has been discontinued in the US for >1 year. 2017;26(1):64–69. You quickly do the math and realize the Kcentra® dose should be 2075 units. anticoagulation-related intracerebral hemorrhage JAMA 2015;313(8):824-36 4. The patient was admitted for headache after sustaining a mechanical fall. WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. 1 One potential adverse effect of anticoagulation is bleeding, including intracranial hemorrhage (ICH). Direct thrombin inhibitor - … A single dose of Kcentra is determined by the patient’s pretreatment INR and weight. *Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 20–31 Factor IX units/mL after reconstitution. The actual potency for 500 unit vial ranges from 400–620 units/vial. Repeat dosing is not supported by clinical data and is not recommended. INTRODUCTION. (1) Individuals with an INR greater than 6 receive 50 U/kg. Guidelines for the Acute Treatment of Cerebral Edema in Neurocritical Care Patients. If 4-8 hours after dose: give 0.5 mg for each 1 mg of enoxaparin or 100 units of dalteparin and tinzaparin. Prospective, observational, multicenter. Twenty-eight (71.7%) of patients included in the efficacy analysis achieved an INR of < 1.7 following Kcentra® administration. One patient required repeat Kcentra® dosing. Patients with an INR ranging from 2 to less than 4 receive 25 U/kg, while those with an INR between 4 and 6 receive 35 U/kg. Uncontrolled hypertension (HTN) is the most common cause of spontaneous ICH. Another consideration is the increased risk of bleeding with In available clinical trials, Kcentra® was shown to be non-inferior Subsequent radiographic imaging showed a large intra-parenchymal hemorrhage with midline shift. Neurocrit Care. Inclusion Criteria: Treatment of life-threatening bleeding or major bleeding associated with hemodynamic instability in patients taking warfarin, rivaroxaban or apixaban (including those who present with intracranial hemorrhage and declining neurologic status) You call your ED pharmacist who states the dose is 25 units/kg if INR is 2 to <4, 35 units/kg if INR is 4-6, and 50 units/kg for INR >6. Preparing for the Bleed. Indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with: Need for urgent surgery/invasive procedure or. Intraparenchymal hemorrhage accounts for 90 % of all VKA-associated deaths [], and both mortality rates and functional outcomes are worse for those with VKA-associated intraparenchymal hemorrhage compared to non-coagulopathic intraparenchymal hemorrhage [27–29].The increased morbidity and … Intervention • 10 mg Vitamin K IV -AND- • 3F-PCC dose relative to baseline INR Endpoints 1°) INR values 50 kg received Kcentra® 1,500 units once, while patients < 50 kg received Kcentra® 1,000 units once. (i.e., gastrointestinal, intracranial hemorrhage, visible, musculoskeletal, etc.). Kcentra 50 units/kg IV o May repeat dose in 12 hours if bleeding continues Maximum dose 5000 units/day o Dosing may change based on bleeding severity and thrombotic risk of patient DIC Systemic thromboembolism Contains heparin. **Patients can be given a conservative dose of 1500 units x 1 dose with a repeat INR taken 30-60 minutes post dose administration. Later in their series, they report effective preoperative reversal of warfarin anticoagulation with progressively smaller Kcentra is therapeutically equivalent to Beriplex, which has been marketed outside of the US since 1996. Contraindicated in patients with known heparin-induced thrombocytopenia (HIT). KCentra Contents and Dosing. Frontera JA, Lewin JJ 3 , Rabinstein AA, et al. ... Hemorrhage intracranial (2.9%) Mental status changes (2.9%) Increased BP/hypertension (2.9%) ... resumption of anticoagulation should be carefully considered following administration of Kcentra and Vitamin K. Acute major bleeding. total units of Factor IX contained in the product) is based upon the patient’s body weight and INR (for warfarin reversal). 2-5. A low dose of andexanet alfa (400 mg bolus given over 15 to 30 min followed by a continuous infusion of 4 mg/min for 120 min) was administered to patients on apixaban and those who had last taken rivaroxaban >7 h ago. The dose is determined by the patient’s pre-dose INR and body weight. in 4 hours. The following are key points to remember from this 2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants (OACs): Use of direct oral anticoagulants (DOACs) is common for conditions such as atrial fibrillation and venous thromboembolism. ICH intracranial hemorrhage INR international normalized ratio ITT-E intention-to-treat efficacy ... Dosing of Kcentra is determined using the patient’s baseline international normalized ratio (INR) and body ... *Kcentra non-inferior to plasma if lower limit of 95% CI > –10%; Kcentra superior to … 2. to increase the strength by diminishing the bulk of, as of a liquid; to condense. Beriplex®, CSL Behring) have been available in Europe and Canada since 1996. The risk of hemorrhage is often associated with the intensity of anticoagulation. Persons who use oral anticoagulants (OACs) have a 7- to 10-fold higher risk of spontaneous ICH compared with those not receiving treatment.4 It is estimated that nearly 12% of all ICHs may be related to the use of OACs, with mortality occurring in 50% of patients with anticoagulation-related ICH.4,8,9 The vitamin K antagonist warfarin has been the most widely used oral anticoagulant since its introduction in 1954. Until recently, warfarin-associated ICH in the United States was typically treated … When calculating the Kcentra dose, it is important to check each vial for Factor IX units, since each lot can vary in potency. Kcentra Dosing: Warfarin Reversal (FDA approved) Ø Dosed on actual body weight up to 100 kg Ø Max rate of IV administration: 8. Cannot re-dose Kcentra ® Rivaroxaban (Xarelto ), Apixaban (Eliquis ®) or Edoxaban (Savaysa ®) Yes or Unknown Kcentra ® 50 units/kg IV x 1 Max dose: 5000 units . Ordering: i. 17. PT >16 secs Kcentra (PCC) 25 units/kg via slow IV infusion X 1 No additional treatment indicated, monitor INR as clinical condition indicates No additional treatment indicated, monitor clinical condition Major Bleeding: Defined as intracranial hemorrhage or significant decrease in the hemoglobin concentration resulting in hemodynamic Blood pressure management, coagulopathy reversal and intracranial pressure control are the mainstays of acute ICH treatment. 9 Trauma patients with uncontrollable bleeds, patients with large blood vessel rupture, and patients with severe intracranial hemorrhage were all excluded. *Repeat dosing is not recommended (has not been studied). One patient presented with hemopericardium, cardiac tamponade, and shock, and 3 patients presented with intracranial hemorrhage. risk of intracranial hemorrhage vs warfarin Mantha S, et al. Population 46 patients with acute symptomatic intracranial hemorrhage and INR>/= 2. c. Doses will be rounded to the nearest 500 units by the verifying pharmacist. Similar products under different proprietary names (e.g. Infuse the remainder as a slow infusion over the next 8 hours. In patients without hypofibrinogenemia (e.g., intracranial hemorrhage, cardiac tamponade, soft tissue injury) in whom mechanical hemostasis cannot be achieved, ... many previous reports used that dosing regimen. Guideline for Reversal of Antithrombotics in Intracranial Hemorrhage: A Satement for Healthcare 9. Our protocol now recommends 1500 units for intracranial hemorrhage, and 1000 units for all other bleeds, in conjunction with vitamin K. Providers have the option to give an additional 500 units based on patient specific intracranial hemorrhage. For reversal of warfarin, Kcentra 25 units/kg x 72 kg (1800 units) was given along with a vitamin K 10 mg IV infusion. prothrombin complex concentrate: [ kon´sen-trāt ] 1. to bring to a common center; to gather at one point. Outcomes following VKA-associated intracranial hemorrhage can be devastating. The risk of mortality following intracranial hemorrhage in a patient on warfarin therapy has been estimated to range from 16-80% (8). Early airway protection, control of malignant HTN, urgent reversal of … ®After KCentra dose is complete, administer a 50 mL bag of normal saline using the same IV tubing at the same rate as KCentra® dose to ensure administration of full dose. (1) Dosing varies by the patient's weight and underlying INR. The minimum total dose that can be ordered is 500 units, and the maximum dose is 5000 units. The following are key points to remember from this 2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants (OACs): Use of direct oral anticoagulants (DOACs) is common for conditions such as atrial fibrillation and venous thromboembolism. If the INR ≥ 2, a supplemental dose based upon the INR reading should be given. The proportion of subjects with effective hemostasis was 72.4% in the KCENTRA group and 65.4% in the plasma group. B. Coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa®) 1. Recent advances in neuroimaging, organised stroke care, dedicated Neuro-ICUs, medical and surgical management have improved the management of ICH. You thank her for the info, place the Kcentra® order, and ask her to help retrieve and prepare Kcentra® STAT. Ordering: i. Methods: According to the 4F-PCC fixed-dosing protocol, patients with warfarin-induced intracranial hemorrhage (ICH) with actual body weight > 50 kg received Kcentra® 1,500 units once, while patients < 50 kg received Kcentra® 1,000 units once. View: A Statement for Healthcare Professionals from the Neurocritical Care Society, endorsed by the Society for Critical Care Medicine and the American Association of Neuroscience Nurses. We retrospectively reviewed our use of a low-dose (15 units/kg) strategy of 4-factor PCC (4F-PCC) on warfarin reversal (INR 1.6–1.9) in the setting of both traumatic and spontaneous intracranial bleeding. Intracranial hemorrhage: Includes intraparenchymal, subdural, epidural, and subarachnoid hemorrhages. QOE) § 2017 ACC Consensus on Management of Bleeding on Oral Anticoagulants o Suggest both fixed- and weight-based Kcentra dosing option § They recommend 1000 unit fixed dose Kcentra for “any bleed” and The median (IQR) presenting INR was 1.8 (1.7, 1.9) which decreased to 1.3 (1.2, 1.3) following the administration of low-dose 4F-PCC (median dose = 1062 units; 15.2 units/kg). Kcentra: coumadin reversal in acute major bleeding or need for urgent surgery: Pretreatment INR: 2 to <4: Administer 25 units/kg; maximum dose: 2,500 units. Neurocrit Care 2016 Feb;24(1):6-46. Desmopressin (DDAVP®) 0.3mcg/kg may be of value (mechanism unknown, effect somehow related to platelets, endothelial surface, FVIII and von Willebrand factor, … B. Coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa®) 1. If bleeding continues, a second dose of protamine 25mg intravenously can be given. 1000 IU 4F-PCC (Octaplex) INR correction to <1.5 within 1 hour: 71.8% Median INR= 2.6. Potentially fatal hemorrhage Symptomatic bleeding in a critical area or organ (e.g. Dosage Required for Reversal of VKA Anticoagulation in Patients with Acute Major Bleeding Reconstitute Kcentra with 20 mL of diluent (Sterile Water for Injection, USP) provided with the kit [see Not indicated for urgent reversal of VKA anticoagulation in patients without acute major bleeding For 80 kg patient with INR 5.0: 35 units/kg x 80 kg = 2800 units; For vial with actual potency of 30 units/mL Factor IX, 93 mL would be administered (2800 units ÷ 30 units/mL = 93 mL) Dosing Considerations. Suggested Kcentra Dosing Algorithm for Life-Threatening Bleeding Caused by Warfarin16 Pretreatment INR 2 to G4 4 to 6 96 Dose* of Kcentra (units** factor IX) per kilogram of actual body weight 25 35 50 Maximum dose,† U 2,500 3,500 5,000 *Dosing is based on body weight. –Kcentra •Advantages –Less volume –Rapid administration –Quicker reversal •Disadvantages –Heparin induced thrombocytopenia •Bebulin •Kcentra –Thrombosis Frontera JA, et al. The two most common primary sites of bleeding were intracranial (64%) and gastrointestinal (26%). There is recognized inter-institutional variability with the use of I4F-PCC, especially as it relates to dosing practices. Methods: A retrospective electronic medical record review of 63 patients with warfarin-related intracranial hemorrhage between 2007 and 2010 in an integrated health … For VKA reversal, Kcentra is dosed to correct INRs of 2.0 or greater per the package insert. The risk of hemorrhage is often associated with the intensity of anticoagulation. a. BACKGROUND/OBJECTIVE: Inactivated four-factor prothrombin complex concentrate (I4F-PCC, Kcentra® ) has become an important agent for the urgent or emergent reversal of bleeding associated with vitamin K antagonists such as warfarin. Example dosing calculation. Intracerebral haemorrhage (ICH) is the most devastating and disabling type of stroke. ... released a guideline for anticoagulation reversal in intracranial hemorrhage (1). ... with intracranial hemorrhage and declining neurologic status) ®After KCentra dose is complete, administer a 50 mL bag of normal saline using the same IV tubing at the same rate as KCentra® dose to ensure administration of full dose. Kcentra is for intravenous use only. Guideline for reversal of antithrombotics in intracranial hemorrhage.
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