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Pathology and Laboratory Medicine
Transfusion Essentials

​Emergency Reversal of Warfarin Using Prothrombin Complex Concentrates (PCC's)

Beriplex or Octaplex

SHR Physician and Nursing Protocol for PCC Usage

​PCC required
​Review indications for use to determine the need for Prothrombin Complex Concentrates (PCC's):
​Indications
  • ​INR 1.5 or greater (caused by Warfarin therapy) AND need for immediate Warfarin reversal due to:
    • Major bleeding, and/or
    • Need for an unplanned surgical procedure which cannot be delayed a minimum of 6 hours
Contraindications
  • ​Patients with a known heparin allergy or in suspected or proven Heparin Induced Thrombocytopenia (HIT)
  • IgA deficiency with anti-IgA antibodies (applies to Octaplex® only)

  • Not effective for management of:
    • Disseminated Intravascular Coagulopathy (DIC)
    • Coagulopathy associated with liver dysfunction/disease
    • Massive transfusion
    • Bleeding associated with heparin based anticoagulants, antiplatelet agents or direct thrombin inhibitors (dabigatran/Pradaxa)
​Adjunctive Therapy
  • ​Vitamin K co-administration by intravenous (IV) or oral route is strongly recommended to complete warfarin reversal management. (Do NOT administer by intramuscular or subcutaneous route).
  • Onset of action of Vitamin K given IV is approximately 4 hours
  • Vitamin K dose and route should be tailored to the clinical circumstances, including the severity of warfarin coagulopathy. For most situations, consider oral vitamin K 1-5 mg. In the case of life-threatening bleeding, administration of 10 mg Vitamin K slowly by IV infusion is recommended.
Dosage
INR 1.5 – 2.9
INR  3.0-5.0
INR 5.1 or greater
PCC dosage
​1000 IU
​2000 IU
​3000 IU
  • If the INR is unknown and major bleeding is present in a patient known to be taking warfarin, 2000 IU (80 mL) PCC should be administered
  • Maximum dose not to exceed 3000 IU
Ordering
Preparation
  • ​ ​Reconstitute product as indicated on the package insert
    • Use the Mix2Vial® spiking device which contains a 15 um filter
    • Once reconstituted remove the blue portion of the Mix2Vial® device
    • Use a syringe to withdraw the product
    • Must be used immediately after reconstitution
  • If loss of vacuum or ineffective reconstitution occurs:
    • Grasp the outer rim of each of the Mix2Vial® components
    • Unscrew counter clockwise to separate
    • Place both vials on a clean surface
    • Carefully detach blue component of the Mix2Vial® from the diluent vial and discard
    • Swab the diluent vial with an antiseptic swab
    • Without touching the white luer lock tip, attach a clean syringe to this end, tightening firmly
    • Remove clear component of the Mix2Vial® from the product vial (with attached syringe) while maintaining aseptic technique
    • Wipe vial top with antiseptic swab
    • Aspirate estimated volume of air into syringe, equivalent to remaining diluent in vial and expel air into vial
    • Invert vial and draw remaining diluent into syringe
    • Remove clear component of Mix2Vial® with attached syringe from the diluent vial
    • Place the clear component with attached syringe containing the diluent into the product vial
    • Carefully push diluent into the product vial and proceed as usual
Administration
  • Infusion rate should not exceed:
    • ​ ​Beriplex® 8 mL/min
    • Octaplex® 2-3 mL/min
  • Blood administration set is not required; product is considered filtered (the Mix2Vial® device contains a filter)
  • Syringe can be placed on an infusion pump or given by IV push
  • No other drugs/solutions can be co-administered in the same line while a PCC is being infused
  • Flush tubing with normal saline
  • Must be infused within 3 hours of reconstitution
Monitoring
  • ​ ​INR should be tested:
    • 10-30 minutes post PCC dose AND 6 hours post PCC dose
    • Repeat thereafter if clinically indicated
  • PCC effect is immediate and will last 6-12 hours post infusion. Expected post infusion targeet INR is less than or equal to 1.5 (complete warfarin reversal)
  • No additional monitoring is required
  • Adverse reactions including immediate allergic complications are rare. Thrombosis risk is at least 1 in 100, and dependent on individual patient risk factors and PCC dose.


​If you choose to print this information, it is valid only on date of print.

Laboratory Controlled Document JA-57 v5

Last Modified: Friday, October 21, 2016 |
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