An observational, prospective, two-cohort comparison of a fixed versus variable dosing strategy of prothrombin complex concentrate to counteract vitamin K antagonists in 240 bleeding emergencies

Khorsand, Nakisa; Veeger, Nic J. G. M.; Hest, Reinier M. van; Ypma, Paula F.; Heidt, J; Meijer, Karina

doi:10.3324/haematol.2012.063701

Cited by 63 publications

(58 citation statements)

References 23 publications

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“…Median time to infusion reduced from 160 min in the variable dose group to 130 min in the fixed dose group. Although follow-up INR was higher after an initial dose as compared to the variable dose, clinical outcome was non-inferior or even better in the fixed dose group [14]. It was therefore hypothesized that a shorter door-to-needle time could be related to a comparable of even better clinical outcome.…”

Section: Discussionmentioning

confidence: 99%

Fixed Versus Variable Dosing of Prothrombin Complex Concentrate in Vitamin K Antagonist-Related Intracranial Hemorrhage: A Retrospective Analysis

et al. 2016

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BackgroundMillions of patients receive vitamin K antagonist (VKA) therapy worldwide. Annually 0.2–1 % of all VKA users develops an intracranial hemorrhage (ICH). Prothrombin complex concentrate (PCC) is administered to restore the INR ≤ 1.5 in an attempt to limit hematoma growth. In order to facilitate PCC dosing, our hospital recently changed from a variable dose based on bodyweight, baseline- and target-INR, to a fixed 1000 IU fIX PCC dosing protocol for ICH.MethodsIn a before and after design, we compared successful achievement of an INR ≤ 1.5 with a fixed dosing strategy versus the variable dosing strategy of PCC in patients presenting with intracranial bleeding complications of VKA. Data of the two cohorts of patients were retrospectively collected from medical records.ResultsA median dosage of 1750 IU was given per patient in the variable dose group (n = 25) versus 1000 IU in the fixed dose group (n = 28). In the intention-to-treat analysis, 96 % achieved an INR ≤ 1.5 after an initial dose in the variable dose cohort compared to 68 % in the fixed dose cohort (p = 0.01). An additional dose was given in 2 (8 %) versus 9 (32 %) patients, respectively (p = 0.04). The median door-to-PCC-order time was 42 versus 32 min (p = 0.37) and the door-to-needle time was 81, respectively 60 min (p = 0.42).ConclusionThe fixed dose protocol necessitates additional PCC infusions more frequently to achieve a target INR ≤ 1.5. Door-to-order and door-to-needle time were shorter but, in this small cohort, not significantly so. The effect on clinical outcome remains unknown.

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Section: Discussionmentioning

confidence: 99%

Fixed Versus Variable Dosing of Prothrombin Complex Concentrate in Vitamin K Antagonist-Related Intracranial Hemorrhage: A Retrospective Analysis

et al. 2016

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“…Only four of the most recent trials used a more specific scale for this purpose. For instance, in a clinical trial, Khorsand et al .…”

Section: Discussionmentioning

confidence: 99%

“…For instance, in a clinical trial, Khorsand et al . used a specified outcome scale for visual and non‐visual bleeds. Sarode et al .…”

Section: Discussionmentioning

confidence: 99%

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Assessment of effectiveness of major bleeding management: proposed definitions for effective hemostasis: communication from the SSC of the ISTH

Khorsand

Majeed

Sarode

et al. 2016

Journal of Thrombosis and Haemostasis

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“…Manufacturer-recommended dosing of 4F-PCC is determined by the pretreatment INR and the patient's body weight ( 18 Another potential dosing strategy includes using weight-based dosing but at lower overall doses (15-25 IU/kg) compared to that recommended by the manufacturer (25-50 IU/kg). One study found a reduced incidence of thromboembolic events (TEEs) with this protocol.…”

Section: F-pcc Dosingmentioning

confidence: 99%

Four-factor prothrombin complex concentrates: effectiveness in the reversal of anticoagulation

Gavva¹,

Reddy²,

Sarode³

2017

IJCTM

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Vitamin K antagonists (VKAs) continue to be the most commonly prescribed class of oral anticoagulants worldwide for the treatment and prevention of venous or arterial thromboembolic events (TEEs). While VKAs are effective at reducing the incidence of TEEs, the risk of major bleeding remains significant. In patients taking VKAs and presenting with clinically significant bleeding or undergoing an emergent procedure, a rapid, effective, and safe reversal agent is required. Available options for the reversal of VKAs include plasma, vitamin K, 3-factor prothrombin complex concentrate (3F-PCC), or 4-factor prothrombin complex concentrate (4F-PCC). Herein, we review the growing evidence that supports using 4F-PCC over both plasma and 3F-PCC for emergent VKA reversal. We also discuss the various dosing options and safety profile of 4F-PCC. In addition, we summarize the limited data available for 4F-PCC in reversing the effects of direct oral anticoagulants and the management of other coagulopathic bleeding.

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An observational, prospective, two-cohort comparison of a fixed versus variable dosing strategy of prothrombin complex concentrate to counteract vitamin K antagonists in 240 bleeding emergencies

Cited by 63 publications

References 23 publications

Fixed Versus Variable Dosing of Prothrombin Complex Concentrate in Vitamin K Antagonist-Related Intracranial Hemorrhage: A Retrospective Analysis

Fixed Versus Variable Dosing of Prothrombin Complex Concentrate in Vitamin K Antagonist-Related Intracranial Hemorrhage: A Retrospective Analysis

Assessment of effectiveness of major bleeding management: proposed definitions for effective hemostasis: communication from the SSC of the ISTH

Four-factor prothrombin complex concentrates: effectiveness in the reversal of anticoagulation

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