Key result
Four-factor prothrombin complex concentrate (4F-PCC) increased peak thrombin generation by 76% at 30 minutes postinfusion compared to saline in healthy volunteers dosed with apixaban (p=0.025).
Why the study?
Does four-factor prothrombin complex concentrate (4F-PCC) reverse impairment of thrombin generation in healthy volunteers dosed with apixaban?
RCT (n=12)
assessor-blinded
two-period crossover
Does four-factor prothrombin complex concentrate (4F-PCC) reverse impairment of thrombin generation in healthy volunteers dosed with apixaban?
Effect estimate: 76% higher
p-value: p=0.025
4F-PCC partially reverses apixaban-induced impairment of thrombin generation in healthy volunteers, though it does not affect anti-Xa levels.
4F-PCC partially reverses apixaban effects on thrombin generation in volunteers; confirms surrogate reversal but leaves clinical outcomes open.
It was hypothesized that the four-factor prothrombin complex concentrate (4F-PCC) Kcentra 25 unit/kg would reverse impairment of thrombin generation in healthy volunteers dosed with apixaban to steady state. In this randomized, two-period crossover, assessor-blinded trial, 12 healthy subjects received 5 mg apixaban every 12 h. Three h after the fifth dose, four-factor prothrombin complex concentrate (4F-PCC) 25 unit/kg or saline were infused. Serial blood samples were assessed for thrombin generation using PPP-reagent and PPP-reagent low, anti-Xa, PT, and PTT assays. Geometric mean ratio was calculated at 30 min postinfusion, and at 24, 48, and 72 h. Peak thrombin generation was 76% higher at 30 min postinfusion with 4F-PCC (p = 0.025). The difference declined to 24% at 24 h and resolved by 48 h. Other thrombin generation parameters were also partially normalized. There was no difference between 4F-PCC and saline in anti-Xa assessment at 30 min or later time points.
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Nagalla et al. (2016) conducted an RCT in Healthy volunteers (n=12). Four-factor prothrombin complex concentrate (4F-PCC) vs. Saline was evaluated on Peak thrombin generation at 30 min postinfusion (76% higher, p=0.025). Four-factor prothrombin complex concentrate (4F-PCC) increased peak thrombin generation by 76% at 30 minutes postinfusion compared to saline in healthy volunteers dosed with apixaban (p=0.025).
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