//fpnotebook.com/
Prothrombin Complex Concentrate
Aka: Prothrombin Complex Concentrate, Prothrombin Drug Combination, PCC, Beriplex, Octaplex, Kcentra, Cofact, PCC3, PCC4
- Components
- Factor II
- Factor VII (present only in four factor PCC)
- Factor IX
- Factor X
- Protein C (not present in all formulations)
- Protein S (not present in all formulations)
- Heparin (to prevent factor activation)
- Formulations: Prothrombin Complex Concentrate
- PCC3 - Three factor (II, IX, X)
- PCC4 - Four factor (II, VII, IX, X)
- Kcentra (U.S., 2013)
- Octaplex
- Beriplex
- Indications
- First-line management of life threatening Hemorrhage in unstable patients on Anticoagulants (e.g. Warfarin)
- Given as part of Massive Hemorrhage protocol (along with pRBC and Platelets), replacing the FFP component
- Contraindications
- Disseminated Intravascular Coagulation
- Heparin-Induced Thrombocytopenia
- Mechanism
- Concentrated extract from fresh-frozen plasma (factors are at 25 fold higher concentration than FFP)
- Each PCC vial contains 500 units of Factor IX (equivalent to two 200-250 cc units/bags of FFP)
- Dosing
- Dose calculated for weight up to a maximum of 100 kg
- Prothrombin Complex Concentrate ( PCC, 4 factor preferred)
- Reversal of Rivaroxaban (Xarelto) or Apixaban (Eliquis) with acute major bleeding
- Dose: 50 Units/kg (up to 5000 units) every 24 hours until bleeding stabilized
- Reversal of Vitamin K Antagonists (e.g. Warfarin) with acute major bleeding
- Coadminister Vitamin K
- Dose based on Factor IX units
- Pre-dose INR 2 to 4
- PCC 25 units/wtKg up to 2500 units Factor IX
- Pre-dose INR 4 to 6
- PCC 35 units/wtKg up to 3500 units Factor IX
- Pre-dose INR >6
- PCC 50 units/wtKg up to 5000 units Factor IX
- Precautions
- Do not give after 6-7 hours from onset of Hemorrhage (paradoxically increases risk of bleeding)
- Limit PCC to a maximum of 2 doses
- PCC lasts for less than one day
- Vitamin K should be given concurrently for a sustained effect
- Disadvantages (compared with FFP)
- Cost is $4500 (twenty times that of the $250 FFP dose)
- Limit use to life-threatening bleeding events
- Cost limits emergency availability at smaller, rural medical centers
- Advantages (compared with FFP)
- Twice as fast as FFP in Coagulopathy reversal
- Time to reversal 5.7 hours (compared with 11.8 hours for FFP)
- PCC is a single dose every 24 hours (compared with multiple doses of FFP)
- Half the adverse effects of FFP
- Adverse event rate 9.7% (compared with 19.5% for FFP)
- Similar rate of thromboembolic complications (VTE) as with FFP (despite more rapid Coagulopathy reversal)
- Lower rate of transfusion and Allergic Reactions compared with FFP
- No risk of Transfusion-Related Acute Lung Injury (TRALI)
- Anaphylactoid reactions may still occur
- Much less volume required
- PCC volumes are 0.1 to 0.15 Liters compared with 1 to 2 Liters FFP
- Fluid Overload does not occur with PCC, but occurs in 6-7% of patients given FFP
- Better outcomes (variable)
- PCC treated patients required only half of Blood Products transfused (compared with FFP per Hickey study)
- PCC group required 1.4 units pRBC
- FFP group required 3.2 units pRBC
- However, another study demonstrated no better outcomes with PCC (Sarode study)
- PCC study demonstrated no better bleeding control (despite faster INR correction)
- Mortality in the PCC group (10 patients died) was double the FFP group (5 patients died) at 45 days
- Sarode (2013) Circulation 128(11): 1234-43 [PubMed]
- Faster preparation and infusion times
- PCC
- Does not require thawing
- Infuses in 25 minutes
- FFP
- Thaws in 20 min (45 C water bath) to 45 min (37 C water bath)
- Infuses in 30-120 minutes
- FFP must be used within 4 hours of thawing
- References
- Hickey (2013) Circulation 128(4): 360-4 [PubMed]
- Adverse Effects
- Headache
- Nausea or Vomiting
- Hypotension
- Arthralgias
- Thromboembolism (e.g. CVA, MI)
- Identified in initial studies
- Subsequent study found no difference in Clot Formation when compared with FFP
- Milling (2016) Ann Emerg Med 67(1): 96-105 +PMID:26094105 [PubMed]
- References
- Arora and Menchine in Herbert (2013) EM:Rap 13(12): 1-2
- Franchini (2010) Blood Transfus 8(3): 149–154 [PubMed]