Preliminary evaluation of the safety and efficacy of a self-prepared activated prothrombin complex concentrate

Xu PAN; Yuwei HUANG; Liehuo MAO; Pan SUN; Changqing LI; Xi DU; Li MA

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Preliminary evaluation of the safety and efficacy of a self-prepared activated prothrombin complex concentrate

VernacularTitle:自制活化凝血酶原复合物的安全性和有效性评价
Author: Xu PAN ¹ ; Yuwei HUANG ² ; Liehuo MAO ³ ; Pan SUN ¹ ; Changqing LI ¹ ; Xi DU ¹ ; Li MA ¹
Author Information

1. Institute of Blood Transfusion, Chinese Academy of Medical Sciences& Peking Union Medical College, Chengdu 610052, China
2. Jianyang People′s Hospital, Chengdu 641400, China
3. Zhejiang Int Biologics Marketing Co., Ltd, Hangzhou 310014, China
Publication Type:Journal Article
Keywords: activated prothrombin complex concentrate (aPCC); factor eight bypassing activity (FEIBA); calibrated automated thrombin generation (CAT); thrombotic risk
From: Chinese Journal of Blood Transfusion 2026;39(8):1004-1011
CountryChina
Language:Chinese
Abstract: Objective: To evaluate the in vitro procoagulant efficacy and in vivo potential thrombogenic risk of self-prepared activated prothrombin complex concentrate (aPCC). Methods: The preparation was administered at a dose of 0.5 IU per milliliter of plasma. For in vitro assays, the self-prepared aPCC concentrate was added to plasma spiked with factorⅧ (FⅧ) inhibitors. Calibrated automated thrombin generation (CAT), prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (Fib) quantification were performed. Normal saline and FEIBA were set as controls to evaluate the procoagulant capacity of the self-prepared aPCC concentrate. For in vivo animal studies, the self-prepared aPCC concentrate was injected into rats via the jugular vein. A ferric chloride (FeCl3) filter paper patch was applied to induce carotid arterial thrombosis. Laser speckle blood flow imaging was used to continuously monitor thrombus formation in the rat carotid artery. Plasma samples were collected from rats for CAT, PT, APTT, TT and Fib testing, with normal saline and FEIBA as controls to evaluate the potential thrombogenic risk of the self-prepared aPCC concentrate. Results: Supplementation with aPCC significantly shortened APTT and PT values in inhibitor-spiked plasma (all P<0.001). There were no statistically significant differences in APTT and PT between FEIBA and self-prepared aPCC (P>0.05). CAT results demonstrated that adding aPCC to inhibitor-containing plasma markedly increased endoge-nous thrombin potential (ETP) and peak thrombin concentration (Peak) (P<0.001), with both parameters higher than those of normal plasma (P<0.05). No significant intergroup difference in ETP was observed between self-prepared aPCC and FEIBA (P>0.05). Carotid blood flow imaging in rats revealed that, compared with FEIBA , thrombi induced by self-prepared aPCC were smaller and less stable, and all underwent spontaneous lysis, accompanied by better restoration of carotid blood perfusion. Conclusion: The self-prepared aPCC restores coagulation function in inhibitor-spiked plasma to a comparable extent as FEIBA , while exhibiting a lower thrombogenic risk.