Stroke Unit, Neurology Clinic, Department of Neuroscience, Nuovo Ospedale Civile S. Agostino-Estense, University of Modena and Reggio Emilia, Modena, Italy.
Department of Oncology and Hematology, Polyclinic of Modena, University of Modena and Reggio Emilia, Modena, Italy.
Adv Clin Exp Med. 2019 Feb;28(2):219-222. doi: 10.17219/acem/84936.
Post-thrombotic intracerebral hemorrhage (ICH) is experienced by 6-8% of stroke patients and is associated with multiple factors, including acquired coagulopathy induced by the thrombolytic drug.
The objective of this study was to assess the outcome of the intravenous (IV) administration of fibrinogen concentrate in a series of acute stroke patients who developed iatrogenic fibrinogen critical depletion after IV thrombolysis.
Of the 39 ischemic stroke patients treated with IV thrombolysis with a severe hypofibrinogenemia requiring infusion with IV fibrinogen concentrate, 30 patients were treated with 2 g of IV recombinant tissue plasminogen activator (rt-PA), followed by further doses until the fibrinogen level reached 200 mg/dL in hemorrhagic patients or 100 mg/dL in non-hemorrhagic patients, and 9 were treated with IV rt-PA followed by endovascular thrombectomy.
Preand post-thrombolysis National Institutes of Health Stroke Scale (NIHSS) scores were statistically different for the Cochran-Mantel-Haenszel test overall (p = 0.0002), at 24-hour evaluation (p = 0.0455) and at 7-day assessment (p = 0.0006). Within the first 7 days post-thrombolysis, the brain computed tomography (CT) scans showed that 20/39 (51.28%) patients had ICH. Of the whole sample, 25.6% of the ICH patients had symptomatic intracerebral hemorrhage (SICH), according to National Institute of Neurological Disorders and Stroke (NINDS) classification. After rt-PA treatment, the median pre-thrombolysis fibrinogenemia of 332 mg/dL significantly dropped to 133 mg/dL (p < 0.0001). After the fibrinogen concentrate infusion, the median level of fibrinogenemia rose to 160 mg/dL, which was significantly higher than the median postthrombolysis levels (p < 0.0001). Recanalization was observed in 25/28 patients (89.29%): complete in 18 and partial in 7 patients. After fibrinogen IV infusion, no thrombotic complications were seen in 37 out of 39 patients (94.77%); 2/39 (0.05%) patients experienced a pulmonary embolism, 1 of them a segmental one.
This study showed the clinical safety of administering IV fibrinogen concentrate in order to increase plasma fibrinogen levels in a series of acute stroke patients with iatrogenic fibrinogen depletion after IV thrombolysis.
血栓后颅内出血（ICH）在 6-8%的中风患者中发生，与多种因素有关，包括溶栓药物引起的获得性凝血障碍。
本研究旨在评估纤维蛋白原浓缩物静脉（IV）给药在一系列接受 IV 溶栓治疗后出现纤维蛋白原严重耗竭的急性中风患者中的疗效。
在 39 例接受 IV 溶栓治疗且纤维蛋白原严重降低需要输注 IV 纤维蛋白原浓缩物的缺血性中风患者中，30 例患者接受 2g 重组组织型纤溶酶原激活剂（rt-PA）治疗，然后根据需要继续给予剂量，直至出血患者的纤维蛋白原水平达到 200mg/dL 或非出血患者的纤维蛋白原水平达到 100mg/dL，9 例患者接受 IV rt-PA 治疗后进行血管内血栓切除术。
总体上，Cochran-Mantel-Haenszel 检验显示溶栓前后国立卫生研究院中风量表（NIHSS）评分存在统计学差异（p=0.0002），在 24 小时评估（p=0.0455）和 7 天评估（p=0.0006）时也存在统计学差异。在溶栓后 7 天内，脑计算机断层扫描（CT）显示 39 例患者中有 20 例（51.28%）发生 ICH。在整个样本中，根据国立神经病学与卒中研究所（NINDS）分类，25.6%的 ICH 患者发生症状性颅内出血（SICH）。在 rt-PA 治疗后，332mg/dL 的中位溶栓前纤维蛋白原血症显著降至 133mg/dL（p<0.0001）。在纤维蛋白原浓缩物输注后，纤维蛋白原血症的中位数水平上升至 160mg/dL，明显高于溶栓后的中位数水平（p<0.0001）。28 例患者中的 25 例（89.29%）观察到再通：18 例完全再通，7 例部分再通。在给予 IV 纤维蛋白原后，39 例患者中有 37 例（94.77%）未发生血栓并发症；39 例患者中有 2 例（0.05%）发生肺栓塞，其中 1 例为节段性。
本研究表明，在一系列接受 IV 溶栓治疗后出现纤维蛋白原严重耗竭的急性中风患者中，给予 IV 纤维蛋白原浓缩物可增加血浆纤维蛋白原水平，具有临床安全性。
