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Please use current guidelines available on the UHNM intranet for patient treatment
Please use current guidelines available on the UHNM intranet for patient treatment
BACKGROUND
- 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
- Only use PCC where clinically indicated as administration may exacerbate underlying pro-thrombotic states
- There is small risk of disseminated intravascular coagulation (DIC), particularly with repeated dosing
- Clinician direct access from the transfusion laboratory is available for agreed indications to ensure prompt treatment provision in recognised indications - [(RSUH: 0900–1700 hr call 74948 or out-of-hours bleep 390) (County: 0900–1700 hr call 4758 or
- for further details and relevant SOPs see Trust policy C03 or Blood and blood products intranet page
INDICATIONS
- Treatment of patients receiving warfarin or alternative vitamin K antagonists (VKA) experiencing major bleeding i.e. life, limb or eye-threatening bleeding. Includes high clinical suspicion of major haemorrhage pre-imaging
- Patients receiving warfarin or VKA requiring surgery or invasive procedure within the next 6-8 hr, due to clinical urgency only
- May be indicated for patients with major bleeding/pre-operatively receiving direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban – see Bleeding in patient receiving DOAC guideline and seek advice from consultant haematologist (see STAC guideline 'Management of Bleeding in Patients on Antithrombotic Therapy')
- May be indicated for patients with other acquired coagulopathies (e.g. liver disease, cardiac surgery) where there is high risk of transfusion associated circulatory overload (TACO) - seek advice from consultant haematologist
CONTRAINDICATIONS
- Hypersensitivity to the active substance or any of the excipients (see SPC)
- Known allergy to heparin or history of heparin induced thrombocytopenia (HIT)
DOSE
- Dosed in 'international units' (IU) as multiples of 500 IU
- Maximum single dose 3000 IU (120 mL)
For anticoagulant reversal
- Dosed at 25-50 IU/kg according to patient weight and INR (where known) as advised by transfusion laboratory SOP (see Table 1 and 2, plus flowchart below)
- Do not await INR or imaging if high clinical suspicion of major haemorrhage - especially if suspected intracranial bleeding
- For warfarin reversal always ensure vitamin K (phytomenadione) 5 mg IV has been prescribed and administered - as PCC immediately (but only temporarily) reverses the anticoagulant effects of warfarin
- Ensure anticoagulant has been omitted
- Repeat INR 10-20 min post administration (see below re assessing response)
Table 1: PCC dose if major bleeding or urgent surgery/procedure but valid INR not yet available
Weight (kg) | PCC dose (25 units/kg) |
---|---|
≤60 | 1500 units |
61-80 | 2000 units |
81–100 | 2500 units |
>100 | 3000 units |
Table 2: PCC dose if major bleeding or urgent surgery/procedure plus INR available and valid (i.e. taken within 8 hr and assess possible impact of previous vitamin K use)
INR | Weight (kg) | PCC issue | PCC dose |
---|---|---|---|
1.6–1.9 | n/a | 500 iu | |
2.0–3.5 | ≤60 | 1500 units | 25 units/kg |
61–80 | 2000 units | ||
81–100 | 2500 units | ||
>100 | 3000 units | ||
3.6-5.0 | ≤60 | 2000 units | 33 units/kg |
61–75 | 2500 units | ||
>75 | 3000 units | ||
>5.0 | ≤60 | 2500 units | 40 units/kg |
>60 | 3000 units |
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)
ADMINISTRATION
- Commence infusion at 1 mL/min and 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 to avoid wastage
ASSESSING RESPONSE TO TRANSFUSION
- Post PCC administration, assess and document bleeding symptom severity according to WHO Bleeding 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 Datix where indication is 'major bleeding on anticoagulation' and discuss with STAC registrar on 15458