背景:纤维蛋白原γ链肽包被,腺苷5'-二磷酸(ADP)包封的脂质体(H12-ADP-脂质体)是促进出血部位血小板血栓形成的有效止血佐剂。尽管我们已经报道了这些脂质体在兔体外循环凝血病模型中的功效,我们还没有解决他们高凝潜力的可能性,尤其是在人类身上。
目的:考虑到其未来的临床应用,我们在此研究了体外循环手术后接受血小板输注的患者的血液样本在体外使用H12-ADP-脂质体的安全性.
方法:纳入10例体外循环手术后接受血小板输注的患者。在以下3点收集血液样本:在切口时,在体外循环结束时,血小板输注后立即。将样品与H12-ADP-脂质体或磷酸盐缓冲盐水(PBS,作为控件),血液凝固,血小板活化,并评估血小板-白细胞聚集体的形成。
结果:用H12-ADP脂质体孵育的患者血液与用PBS孵育的血液在凝血能力上没有差异,血小板活化程度,和血小板-白细胞聚集在任何时间点。
结论:H12-ADP脂质体没有引起异常凝血,血小板活化,或体外循环后接受血小板输注的患者血液中的血小板-白细胞聚集。这些结果表明,H12-ADP脂质体可能安全地用于这些患者,在出血部位提供止血,而不会引起相当大的不良反应。未来的研究需要确保人类的强大安全。
Fibrinogen γ-chain peptide-coated, adenosine 5\'-diphosphate (ADP)-encapsulated liposomes (H12-ADP-liposomes) are potent hemostatic adjuvants that promote platelet thrombi formation at bleeding sites. Although we have reported the efficacy of these liposomes in a rabbit model of cardiopulmonary bypass coagulopathy, we are yet to address the possibility of their hypercoagulative potential, especially in human beings.
Considering its future clinical applications, we herein investigated the safety of using H12-ADP-liposomes in vitro using blood samples from patients who had received platelet transfusion after cardiopulmonary bypass surgeries.
Ten patients receiving platelet transfusions after cardiopulmonary bypass surgery were enrolled. Blood samples were collected at the following 3 points: at the time of incision, at the end of the cardiopulmonary bypass, and immediately after platelet transfusion. After incubating the samples with H12-ADP-liposomes or phosphate-buffered saline (PBS, as a control), blood coagulation, platelet activation, and platelet-leukocyte aggregate formation were evaluated.
Patients\' blood incubated with H12-ADP-liposomes did not differ from that incubated with PBS in coagulation ability, degree of platelet activation, and platelet-leukocyte aggregation at any of the time points.
H12-ADP-liposomes did not cause abnormal coagulation, platelet activation, or platelet-leukocyte aggregation in the blood of patients who received platelet transfusion after a cardiopulmonary bypass. These results suggest that H12-ADP-liposomes could likely be safely used in these patients, providing hemostasis at the bleeding sites without causing considerable adverse reactions. Future studies are needed to ensure robust safety in human beings.