Restart TICrH: An Adaptive Randomized Trial of Time Intervals to Restart Direct Oral Anticoagulants after Traumatic Intracranial Hemorrhage
Restart TICrH: An Adaptive Randomized Trial of Time Intervals to Restart Direct Oral Anticoagulants after Traumatic Intracranial Hemorrhage
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DOI：
10.1089/neu.2020.7535
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发表时间：
2021-04-06
影响因子：
4.2
通讯作者：
Lip, Gregory Y. H.
中科院分区：
文献类型：
--
作者：
Milling, Truman J., Jr.;Warach, Steven;Lip, Gregory Y. H.
抗凝剂可预防房颤和静脉血栓栓塞（VTE）患者的血栓形成和死亡，但也会增加出血风险。受益/风险比有利于大多数患者的抗凝治疗。然而，有些会有出血并发症，如老年患者常见的绊倒和跌倒脑损伤，导致创伤性颅内出血。然后，临床医生必须做出关于何时重新开始抗凝剂的艰难决定。过早重新开始可能会使出血恶化。太晚重新开始治疗会导致血栓性事件，如缺血性中风和静脉血栓栓塞，这是抗凝治疗的首要适应症。自发性颅内出血患者重新开始治疗的数据较多，这与外伤性颅内出血有很大不同。自发性颅内出血增加了再出血的风险，因为内源性血管改变是广泛的和不可逆的。相比之下，创伤性病例是由头部打击引起的，通常是一个孤立的事件，预示着未来的风险较小。临床医生普遍认为应该重新开始抗凝治疗，但对何时重新开始抗凝治疗意见不一。这种不确定性导致长时间的重新开始延迟，造成巨大的、潜在可预防的中风和静脉血栓栓塞负担，由于缺乏高质量的证据，这一问题一直没有得到解决。重新开始创伤性颅内出血（“r”区分颅内和脑内）（TICrH）是一项前瞻性、随机、开放标签、设盲、终点反应适应性临床试验，旨在评价延迟重新开始直接口服抗凝治疗（1、2或4周）对创伤性颅内出血后患者血栓事件和出血复合终点的影响。
Anticoagulants prevent thrombosis and death in patients with atrial fibrillation and venous thromboembolism (VTE) but also increase bleeding risk. The benefit/risk ratio favors anticoagulation in most of these patients. However, some will have a bleeding complication, such as the common trip-and-fall brain injury in elderly patients that results in traumatic intracranial hemorrhage. Clinicians must then make the difficult decision about when to restart the anticoagulant. Restarting too early risks making the bleeding worse. Restarting too late risks thrombotic events such as ischemic stroke and VTE, the indications for anticoagulation in the first place. There are more data on restarting patients with spontaneous intracranial hemorrhage, which is very different than traumatic intracranial hemorrhage. Spontaneous intracranial hemorrhage increases the risk of rebleeding because intrinsic vascular changes are widespread and irreversible. In contrast, traumatic cases are caused by a blow to the head, usually an isolated event portending less future risk. Clinicians generally agree that anticoagulation should be restarted but disagree about when. This uncertainty leads to long restart delays causing a large, potentially preventable burden of strokes and VTE, which has been unaddressed because of the absence of high quality evidence. Restart Traumatic Intracranial Hemorrhage (the "r" distinguished intracranial from intracerebral) (TICrH) is a prospective randomized open label blinded end-point response-adaptive clinical trial that will evaluate the impact of delays to restarting direct oral anticoagulation (1, 2, or 4 weeks) on the composite of thrombotic events and bleeding in patients presenting after traumatic intracranial hemorrhage.