PROTHROMBIN COMPLEX CONCENTRATE (OCTAPLEX^®) TRANSFUSION

• To revise the principles of transfusion, see Principles of transfusion and Consent for transfusion guidelines
• 4-factor PCC is a manufactured plasma product containing clotting Factors II, VII, IX and X, plus the natural anticoagulant proteins C and S
• Available as Octaplex^® 500 IU or 1000 IU coagulation factor IX
• Store in controlled temperature <25°C for <2 yr
• Once requested keep in controlled storage at 2–8°C until required

• If in doubt, discuss with haematologist

On warfarin or alternative vitamin K antagonists (VKA)

• See Warfarin overanticoagulation

Major bleeding

• i.e. life, limb or eye-threatening bleeding
• high clinical suspicion of major haemorrhage pre-imaging intra-cerebral bleed
• Haemorrhage with haemodynamic instability
• Major trauma
• Intraocular bleeding (excluding subconjunctival)
• Muscle bleed resulting in compartment syndrome
• Pericardial bleed

Requiring surgery or invasive procedure within the next 6–8 hr

• Due to clinical urgency only

On direct oral anticoagulant (DOAC)

• May be indicated for patients with major bleeding/pre-operatively
• see DOAC: bleeding and seek advice from consultant haematologist

Other acquired coagulopathies (e.g. liver disease, cardiac surgery)

• May be indicated for such patients where there is high risk of transfusion associated circulatory overload (TACO)
• seek advice from consultant haematologist

Direct clinician access to PCC

Clinician direct access

• Available from the transfusion laboratory for agreed indications 

• Hypersensitivity to the active substance or any of the excipients (see SPC)
• Known allergy to heparin or history of heparin induced thrombocytopenia (HIT) 

Cautions

• Administration may exacerbate underlying pro-thrombotic states
• There is small risk of disseminated intravascular coagulation (DIC), particularly with repeated dosing 

• Dosed in ‘international units’ (IU) as multiples of 500 IU
• Maximum single dose 3000 IU (120 mL) 

For anticoagulant reversal

• Dose at 25–50 IU/kg according to patient weight and INR if available and valid
• INR taken within 8 hr. Assess possible impact of previous vitamin K use

• If high clinical suspicion of major haemorrhage, especially if suspected intracranial bleeding, do not await INR or imaging. Dose by weight

• For warfarin reversal, ensure vitamin K (phytomenadione) 5 mg IV prescribed and administered
• as PCC immediately (but only temporarily) reverses the anticoagulant effects of warfarin
• Ensure anticoagulant has been omitted 

As low volume FFP alternative

• Treat each 500 IU PCC as a treatment decision and evaluate clinically ± near patient testing (NPT) of coagulation post dose
• 1 IU PCC has equivalent clotting factor activity to 1 mL plasma (500 IU approximately equivalent to 2 units FFP)

• Commence infusion at 1 mL/min
• Observe closely for allergic reactions/anaphylaxis
• In major bleeding, increase rate to 8–10 mL/min under direct clinical instruction
• Pre-surgery/procedure, increase rate to 2–3 mL/min
• Return unused PCC to transfusion laboratory as soon as possible

• Assess and document WHO bleeding severity score
• For warfarin reversal, repeat INR 10–20 min post PCC administration
• if adequate correction, recheck clotting after 4-6 hours then daily
• if INR ≥1.5 or suboptimal correction and further PCC may be required – seek advice from a consultant haematologist
• Monitor for adverse events of PCC usage, especially thrombosis
• Complete incident form for ‘Bleeding on anticoagulation’
• Discuss with STAC registrar