Overview
VKA treatment
Signs or symptoms of bleeding Emergent or urgent surgery
No Yes
Check INR value < 24 hours
> 24 hours
4 – 10 Interrupt VKA , close follow-up Consider oral vitamin K |
> 10 Interrupt VKA , oral vitamin K 2.5 – 5mg , close follow-up |
Minor bleeding
Use clinical judgement ( withhold VKA , give vitamin K , FFP )
|
Major bleeding
Hold VKA , give 10mg IV vitamin K , PLUS PCC
|
Administer IV vitamin K , 2 – 4mg , and PCC or FFP if needed |
Administer IV vitamin K , 2 – 4mg |
12 , 27 , 28
Figure 2 : Reversal algorithm for VKA-treated patients with supra-therapeutic INR or urgent perioperative surgery .
4
INR in an otherwise stable patient are diet changes , poor compliance , alcohol consumption , undisclosed drugs , or concurrent medication changes causing drug – drug interactions . 3 – 5
Bleeding is one of the major risks associated with VKA therapy . The most common bleeding sites are the gastrointestinal tract ; followed by the urinary tract , nose and skin . However , the most critical bleeds are intracranial and retroperitoneal haemorrhage . The annual rate of major bleeding events in VKAtreated patients ranged from 0.4 % to 7.2 %, with a mortality rate exceeding 13 %, and intracranial haemorrhage resulting in nearly 50 % of the mortality rate . 6 – 9 Depending on the severity of the bleeding events , several management procedures have been adopted to reverse VKA-associated bleeding , including VKA discontinuation , administration of vitamin K , fresh frozen plasma ( FFP ), prothrombin complex concentrates ( PCCs ), and / or recombinant activated human factor VIIa ( rFVIIa ) 10 ( Figure 2 ).
Temporary discontinuation of VKA therapy for a few days could be an appropriate approach for patients with an elevated INR and at high risk of bleeding , or patients with minor bleeding
( Figure 2 ). 11 Administration of vitamin K becomes necessary in cases where VKA reversal is needed , as in major bleeding events , trauma , or urgent medical procedures . Vitamin K can be administered in three different forms : orally ; subcutaneously ( SC ); or intravenously ( IV ). Oral vitamin K is considered effective in patients with supra-therapeutic INR and high risk of bleeding . SC vitamin K , by contrast , has not proved effective in correcting
supra-therapeutic INR . In bleeding patients , the IV route is preferred for administration of vitamin K because it is associated with a relatively faster correction of INR . 10 – 13 The American College of Chest Physicians ’ recommendation is to administer 10mg vitamin K by slow IV infusion over a minimum of 30 minutes to reduce the risk of anaphylaxis reactions associated with IV vitamin K ( reported rate 3 x 10 – 6 ).
A dose of IV vitamin K may need to be repeated at 12-hour intervals if INR remains elevated and the risk of bleeding is still present . 10
Severe and life-threatening bleeding In severe and life-threatening bleeding events , administration of IV vitamin K alone is not considered an adequate approach owing to the delay in achieving VKA reversal ( 12 – 24 hours ). Restoration
“ The most common bleeding sites are the gastrointestinal tract , urinary tract , nose and skin ; however the most critical bleeds are intracranial and retroperitoneal haemorrhage ”
of vitamin K-dependent factors by FFP infusion and / or administration of PCC is essential in these cases to fully manifest and reverse VKA-associated coagulopathy . 11 , 13 Advantages of FFP include its wide availability , long history of use and lower cost compared with other reversal options . The major disadvantages of FFP are the restriction to specific or compatible ABO blood groups and the remarkable association www . hospitalpharmacyeurope . com