Key result
In emergency department patients requiring acute vitamin K antagonist reversal to an INR ≤ 1.5, using the Sanquin dosing protocol for prothrombin complex concentrate resulted in 93% achieving the target INR compared to 69% when the protocol was not followed.
Why the study?
Does prothrombin complex concentrate dosing according to the Sanquin protocol achieve target INR values in ED patients on vitamin K antagonists with acute bleeding?
Cohort (n=60)
No
Does prothrombin complex concentrate dosing according to the Sanquin protocol achieve target INR values in ED patients on vitamin K antagonists with acute bleeding?
The standard dosing protocol for prothrombin complex concentrate is effective for achieving an INR ≤ 1.5 but frequently fails to achieve a target INR of 1.6-2.1, suggesting a need for tailored dosing approaches based on the specific target INR.
BACKGROUND: Co-fact©, prothrombin complex concentrate, is used for restoring the international normalized ratio (INR) in patients on vitamin K antagonists (VKA) presenting with acute bleeding. In this prospective cohort study, we evaluated whether adequate INR values were reached in ED patients using the Sanquin (Federation of Dutch Thrombosis Services) treatment protocol. METHODS: We evaluated this protocol for two target INR groups: group 1, target INR ≤ 1.5 (for life-threatening bleeding/immediate intervention); group 2, target INR 1.6-2.1 (in cases of a minor urgent surgery or serious overdosing of anticoagulant). We specifically wanted to identify both under- and over-treated patients. Reversing VKA anticoagulation therapy to unnecessarily low INR values may involve thrombotic risks. Apart from this risk, the patient is also administered an excess amount of the drug. This means unnecessary costs and may present problems with restoring an anticoagulated state at a later time. RESULTS: In our cohort, the Sanquin dosing protocol was followed for 45/60 patients. It appeared that out of the 41 patients in group 1 (target INR ≤ 1.5), 35 (85%) achieved the goal INR. This occurred more often than for the 19 patients in group 2 (target INR 1.6-2.1), where only 6 (32%) achieved the goal INR. Using the protocol resulted in a positive trend toward better INR reversal in group 1. In group 2, no relation between using the protocol and achieving the desired INR value was detected. Physicians ignoring the proposed dose of Co-fact© prescribed significantly less Co-fact© (even when correcting for patient weight). It appeared that patients in group 1 had a significantly lower baseline INR than patients in group 2. Group 2 patients, on the other hand, had a baseline INR > 7.5 in 53% of the cases. CONCLUSION: In our cohort, for most patients in INR group 2 treated with Co-fact©, the achieved INR value was outside the desired range of 1.6-2.1. The supra-therapeutic range of baseline INR in group 2 may have contributed to the different kind of bleeding witnessed in this patient group. Our results support the idea that treatment of patients on vitamin K antagonists with Co-fact© could benefit from a slightly different approach, taking into account the INR value to which the patient needs to be reversed.
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Roodheuvel et al. (2013) conducted a cohort in Acute bleeding or need for acute reversal in patients on vitamin K antagonists (n=60). Sanquin dosing protocol for prothrombin complex concentrate (Co-fact) vs. Non-adherence to the dosing protocol was evaluated on Achieving target INR ≤ 1.5 (Group 1). In emergency department patients requiring acute vitamin K antagonist reversal to an INR ≤ 1.5, using the Sanquin dosing protocol for prothrombin complex concentrate resulted in 93% achieving the target INR compared to 69% when the protocol was not followed.
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