Appendix 3 PCC Warfarin Reversal

Transcription

1 Appendix 3 PCC Warfarin Reversal

2 Reversal of Warfarin and Analogues 1. Principle of Procedure Guidelines for the Reversal of Oral-anticoagulation in the Event of Life Threatening Haemorrhage Prothrombin Complex Concentrate (PCC) is made from human plasma and it contains the human coagulation factors II, VII, IX and X, plus Protein C and Protein S. The coagulation factors II, VII, IX and X are vitamin K-dependent and are important for blood clotting. Lack of any of these factors will lead to an increased tendency to bleed. The replacement of factors II, VII, IX and X with PCC (brand name Beriplex P/N at this Trust) will repair the coagulation mechanisms. Beriplex P/N is presented as powder and solvent. The reconstituted solution is to be given by injection into a vein. 2. Indications for use Prothrombin Complex Concentrates (PCC) such as the brands Beriplex P/N are used for the prevention and treatment of bleeds caused by the acquired or congenital lack of vitamin K-dependent coagulation factors. Fresh Frozen Plasma (FFP) has usually been used in cases of excessive bleeding or to prevent bleeding in patients with abnormal coagulation tests that are undergoing an invasive procedure. It has now been recognised that FFP is not the optimal form of coagulation factor replacement and in the case of a life threatening haemorrhage as a consequence of warfarin or other coumarin therapy. FFP should only be used when PCC is not available or is contraindicated. 3. Sample Requirements Prior to the issue of PCC the following samples must be screened: Full blood count (FBC) Coagulation screen: PT, APTT and Clauss fibrinogen (not derived this is only viable for normal results) Baseline renal and liver function tests A current sample must be available for group and screen to allow the allocation of the product to the patient s record. Any patient on warfarin with a strong suspicion of intracerebral haematoma after a clear head injury should have PCC made available prior to laboratory testing. This decision must be consultant lead. The INR must be checked mins after the PCC has been administered to confirm suitable reversal. The laboratory will issue a standard dose of 2500IU of PCC for these patients.

3 4. Reversal of Oral anti-coagulants (alternatives to WARFARIN) Reversal of thrombin inhibitors Dabigatran - Reversal agent Praxbind (5g Dose) available in A&E fridge. Not life threatening haemorrhage Stop anticoagulant Life threatening haemorrhage Stop anticoagulant Measure Thrombin time to verify if patient anticoagulated Discuss with consultant haematologist for appropriate measures Reversal of factor Xa inhibitors No reversal agent available Rivaroxaban Apixaban Edoxaban Not life threatening haemorrhage: Stop the anticoagulant Life threatening haemorrhage: Stop the anticoagulant Prescribe PCC (Beriplex) 50IU / kg (use INR - above 6) Measure the Thrombin time pre and post to verify reversal Discuss with consultant haematologist for other appropriate measures Note Factor Xa and Thrombin inhibitors are new anticoagulants and there is little evidence in the appropriate reversal in the event of a life threatening haemorrhage so discussion with the consultant haematologist is strongly advised 5. Dose and Administration Stop warfarin and reverse anticoagulation Give vitamin K mg IV slowly (over minutes). This can cause anaphylaxis if given too quickly. Give Beriplex P/N (Prothrombin Complex Concentrate). Calculate the dose according to the INR and weight in kg as per table below: Patient s INR Recommended dose of Beriplex P/N units / kg body weight units / kg body weight Above units / kg body weight This is incorporated into the following dosage guide:

4 The maximum single dosage should not exceed 5000units. It will be issued as 250, 500 and 1000 unit vials as appropriate. For further information refer to the package leaflet. PCC is stored and issued by the Blood Transfusion Department. Contact them on extension 1808 during routine hours or out of hours contact ext An information leaflet will be issued with the product describing the needle-free reconstitution and transfer system. The reconstituted solution should be administered intravenously and given at a maximum rate of 8 ml / minute. (Please note that infusion pumps are set in ml / hour.) The product has a fast onset of action (<10 minutes) and a half life of 6 hours, it is therefore essential to give vitamin K at the same time. Following the infusion of PCC the INR needs to be rechecked at 20 minutes and 6 hours post infusion. Seek further advice if there is no improvement in INR. Fresh frozen plasma (FFP) should be given (15 ml / kg) if Beriplex P/N is not available or contraindicated and contact the Haematologist for clinical advice. FFP has a slower onset of action and may not be as effective. The ampoules contain a mix 2 vial in the box to aid mixing of water and powder, this device is to prevent needle stick injuries. Please prepare according to the following instructions on the next page:

5

6 6. Contraindications to use of Beriplex P/N Known hypersensitivity to any of the components of the product. Risk of thrombosis, angina pectoris, recent myocardial infarction (exception: lifethreatening haemorrhages following overdose of oral anticoagulants, and before induction of fibrinolytic therapy). In the case of disseminated intravascular coagulation, prothrombin complex preparations may only be applied after termination of the consumptive state. Known history of heparin-induced thrombocytopenia. For further information see product SPC accessible on 7. Audit FFP is a blood component and PCC is a plasma product. It is important that they are used Appropriately, and their prescription and rationale for use are recorded in the patient s notes. Ensure that the white crossmatch sheet is signed and returned to the Blood Transfusion Department and that the red/white transfusion report is filed in the patient case notes. Use wisely: Beriplex P/N typically costs 1500 for a typical adult. If further clinical advice is required regarding this product please contact the Haematologist. 7. Related BCSH Guidelines British Committee for Standards in Haematology. Guidelines on oral anticoagulation fourth edition. British Journal of Haematology; 154, British Committee for Standards in Haematology. Guidelines on oral anticoagulation (warfarin): third edition 2005 update. British Society for Haematology; 132, British Committee for Standards in Haematology 2004 a) Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. British Journal of Haematology; 126,