1307

Title

Guidelines for the reversal of warfarin in cases of major haemorrhage using Octaplex

Staff involved in development

Dr D S Thompson Dr J M Voke Dr Mary Evans Janet Clarbour

Staff with overall responsibility for development implementation and review

Dr D S Thompson

Development period

July – December 2006

Date approved by Clinical Guidelines committee

January 2007

Signed by the Chair Clinical Guidelines Committee

M Griffiths

Date for review

Dec 2009

Key words

Anticoagulation reversal Bleeding

Name & Date of Previous Document (if applicable)

N/A

Date document was Equality Impact Assessed:

For completion by CG Committee:

NO:

CG 228

Reversal of warfarin anticoagulation using Octaplex Author Dr D S Thompson December 2006

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Guidelines for the reversal of warfarin in cases of major haemorrhage using Octaplex Octaplex is a prothrombin complex concentrate and should be used for reversal of oral anticoagulants in cases of life limb or sight threatening haemorrhage. These situations include cerebral, intraocular or retroperitoneal haemorrhage, muscle bleed with compartment syndrome, uncompensated bleeding from any orifice with developing shock, and prior to emergency surgery with high risk of bleeding.

Suspected cerebral haemorrhage must be objectively confirmed with urgent crosssectional imaging prior to administration of Octaplex to confirm bleed rather than infarct.

Availability. Octaplex is available from the hospital blood bank, tel 7217, or on-call haematologist out of hours.

Octaplex is only issued on the authorisation of a consultant haematologist.

Product. Octaplex contains clotting factors II, VII, IX, X, protein S and protein C. The product also contains heparin. Each vial of Octaplex contains 500iu factor IX. The dose is conventionally calculated on the desired rise of factor IX. Reconstitution. Each vial is supplied with 20ml solvent, one double ended needle and one filter needle. The instructions supplied with each vial should be followed for drawing up the solvent and reconstitution. The product must be filtered after reconstitution before use, [see packet insert]. Use immediately after reconstitution.

Dose. There is a lack of data on optimum dosing. The following is suggested: INR <5 15 iu/kg INR >5 30 iu/kg Intracerebral bleed 50 iu/kg Administration. Octaplex should be given by slow IV infusion with a syringe pump, starting at a rate of 1 ml/minute, increasing to maximum 3 ml/minute as tolerated. A dose for a 70kg patient may take 30 minutes.

Vitamin K. Octaplex will have immediate effect but as the half life of factor VII is only 6 hours, 5mg IV vitamin K should be given at the same time as the Octaplex.

This will allow synthesis of active coagulation factors to give a sustained response and avoid the need for a second dose of Octaplex.

Monitoring, The INR should be checked before and immediately following completion of the infusion, and at 6 hours.

Contraindications to Octaplex. Sensitivity to heparin or previous heparin induced thrombocytopaenia.

Reversal of warfarin anticoagulation using Octaplex Author Dr D S Thompson December 2006

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Side effects.

Thromboembolic complications. Octaplex should only be used for the reversal of life threatening haemorrhage. When the acute situation is resolved, consider thromboprophylaxis, eg thromboembolic stockings, heparin. The risk is higher in patients with liver disease.

Anaphylactic/anaphylactoid reactions can very rarely occur.

Viral transmission. Octaplex is a blood product, therefore viral transmission may very rarely occur despite viral inactivation steps in preparation.

Documentation. The product must be prescribed as for any blood product and the batch number recorded on the prescription chart.

Haemorrhage on warfarin

Life threatening haemorrhage including any cerebral bleed confirmed by imaging Significant bleeding, (excluding cerebral bleeds) with no haemodynamic compromise

Check INR Octaplex 30iu/kg Vitamin K 5mg IV Stop warfarin Check INR immediately after Octaplex Check INR at 6 hours

Minor bleeding

Vitamin K 2mg iv or 5mg oral Stop warfarin Vitamin K 5mg IV Consider FFP 15ml/kg Stop warfarin Check INR after FFP Check INR at 6 hours

Reversal of warfarin anticoagulation using Octaplex Author Dr D S Thompson December 2006

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