CRASH-3 - tranexamic acid for the treatment of significant traumatic brain injury: study protocol for an international randomized, double-blind, placebo-controlled trial.
CRASH-3 - tranexamic acid for the treatment of significant traumatic brain injury: study protocol for an international randomized, double-blind, placebo-controlled trial.
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DOI：
10.1186/1745-6215-13-87
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发表时间：
2012-06-21
期刊：
影响因子：
2.5
通讯作者：
CRASH-3 Collaborators
中科院分区：
文献类型：
--
作者：
Dewan Y;Komolafe EO;Mejía-Mantilla JH;Perel P;Roberts I;Shakur H;CRASH-3 Collaborators
全世界每年有1000多万人因创伤性脑损伤而死亡或住院。约90%的死亡发生在低收入和中等收入国家。这种情况主要影响年轻人，许多人会经历长期或永久的残疾。社会和经济负担相当沉重。氨甲环酸（TXA）通常给予外科病人，以减少出血和输血的需要。事实证明，它可以将接受输血的患者数量减少约三分之一，将输血量减少约一个单位，并将选择性手术患者进一步手术以控制出血的需要减少一半。CRASH-3试验是一项国际、多中心、实用、随机、双盲、安慰剂对照试验，旨在量化早期给药TXA对外伤性脑损伤患者死亡和残疾的影响。1万名符合资格标准的成年患者将随机接受TXA或安慰剂。创伤性脑损伤的成人，在受伤后8小时内，计算机断层扫描（CT）显示颅内出血或格拉斯哥昏迷评分（GCS）为12或更低，如果负责的医生对是否在该患者中使用TXA有很大的不确定，则可以包括在内。有明显颅外出血的患者将被排除在外，因为有证据表明TXA可以改善这些患者的预后。治疗将需要1 g负荷剂量，然后在8小时内给予1 g维持剂量。无论是否接受分配的治疗，主要分析将基于“意向治疗”。结果将以精确度（95%置信区间）的适当效果估计呈现。主要结局的亚组分析将基于从损伤到随机化的时间、损伤的严重程度、出血的位置和基线风险。相互作用试验将用于测试治疗效果在这些亚组之间是否不同。一项包含10,000名患者的研究将有大约90%的能力检测出全因死亡率从20%到17%相对降低15%。当前对照试验ISRCTN15088122；Clinicaltrials.gov NCT01402882
Worldwide, over 10 million people are killed or hospitalized because of traumatic brain injury each year. About 90% of deaths occur in low- and middle-income countries. The condition mostly affects young adults, and many experience long lasting or permanent disability. The social and economic burden is considerable. Tranexamic acid (TXA) is commonly given to surgical patients to reduce bleeding and the need for blood transfusion. It has been shown to reduce the number of patients receiving a blood transfusion by about a third, reduces the volume of blood transfused by about one unit, and halves the need for further surgery to control bleeding in elective surgical patients. The CRASH-3 trial is an international, multicenter, pragmatic, randomized, double-blind, placebo-controlled trial to quantify the effects of the early administration of TXA on death and disability in patients with traumatic brain injury. Ten thousand adult patients who fulfil the eligibility criteria will be randomized to receive TXA or placebo. Adults with traumatic brain injury, who are within 8 h of injury and have any intracranial bleeding on computerized tomography (CT scan) or Glasgow Coma Score (GCS) of 12 or less can be included if the responsible doctor is substantially uncertain as to whether or not to use TXA in this patient. Patients with significant extracranial bleeding will be excluded since there is evidence that TXA improves outcome in these patients. Treatment will entail a 1 g loading dose followed by a 1 g maintenance dose over 8 h. The main analyses will be on an ‘intention-to-treat’ basis, irrespective of whether the allocated treatment was received. Results will be presented as appropriate effect estimates with a measure of precision (95% confidence intervals). Subgroup analyses for the primary outcome will be based on time from injury to randomization, the severity of the injury, location of the bleeding, and baseline risk. Interaction tests will be used to test whether the effect of treatment differs across these subgroups. A study with 10,000 patients will have approximately 90% power to detect a 15% relative reduction from 20% to 17% in all-cause mortality. Current Controlled Trials ISRCTN15088122; Clinicaltrials.gov NCT01402882
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DOI：
10.1136/bmj.d3795
发表时间：
2011-07-01
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
CRASH-2 Collaborators, Intracranial Bleeding Study
通讯作者：
CRASH-2 Collaborators, Intracranial Bleeding Study
影响因子：
8.3
作者：
Gebel, JM;Jauch, EC;Broderick, JP
通讯作者：
Broderick, JP
影响因子：
8.8
作者：
HORROW, JC;VANRIPER, DF;PARMET, JL
通讯作者：
PARMET, JL
影响因子：
8.8
作者：
Peto R;Pike MC;Armitage P;Breslow NE;Cox DR;Howard SV;Mantel N;McPherson K;Peto J;Smith PG
通讯作者：
Smith PG
影响因子：
8.3
作者：
Figueroa, BE;Keep, RF;Hoff, JT
通讯作者：
Hoff, JT