Division of Burns/Trauma/Critical Care , Department of Surgery, Parkland Memorial Hospital, UT Southwestern Medical Center, Dallas, Texas, USA.
J Trauma Acute Care Surg. 2012 Dec;73(6):1434-41. doi: 10.1097/TA.0b013e31825ac49e.
Our group has created an algorithm for venous thromboembolism prophylaxis after traumatic brain injury (TBI), which stratifies patients into low, moderate, and high risk for spontaneous injury progression and tailors a prophylaxis regimen to each arm. We present the results of the Delayed Versus Early Enoxaparin Prophylaxis I study, a double-blind, placebo-controlled, randomized pilot trial on the low-risk arm.
In this two-institution study, patients presenting within 6 hours of injury with prespecified small TBI patterns and stable scans at 24 hours after injury were randomized to receive enoxaparin 30 mg bid or placebo from 24 to 96 hours after injury in a double-blind fashion. An additional computed tomography scan was obtained on all subjects 24 hours after starting treatment (and therefore 48 hours after injury). The primary end point was the radiographic worsening of TBI; secondary end points were venous thromboembolism occurrence and extracranial hemorrhagic complications.
A total of 683 consecutive patients with TBI were screened during the 28 center months. The most common exclusions were for injuries larger than the prespecified criteria (n = 199) and preinjury anticoagulant use (n = 138). Sixty-two patients were randomized to enoxaparin (n = 34) or placebo (n = 28). Subclinical, radiographic TBI progression rates on the scans performed 48 hours after injury and 24 hours after start of treatment were 5.9% (95% confidence interval [CI], 0.7-19.7%) for enoxaparin and 3.6% (95% CI, 0.1-18.3%) for placebo, a treatment effect difference of 2.3% (95% CI, -14.42-16.5%). No clinical TBI progressions occurred. One deep vein thrombosis occurred in the placebo arm.
TBI progression rates after starting enoxaparin in small, stable injuries 24 hours after injury are similar to those of placebo and are subclinical. The next Delayed Versus Early Enoxaparin Prophylaxis studies will assess efficacy of this practice in a powered study on the low-risk arm and a pilot trial of safety of a 72-hour time point in the moderate-risk arm.
Therapeutic study, level II.
我们小组已经创建了一种用于创伤性脑损伤（TBI）后静脉血栓栓塞预防的算法，该算法将患者分为自发性损伤进展的低、中、高风险，并为每个手臂量身定制预防方案。我们介绍了 Delayed Versus Early Enoxaparin Prophylaxis I 研究的结果，这是一项关于低风险手臂的双盲、安慰剂对照、随机试点试验。
在这项由两个机构进行的研究中，将受伤后 6 小时内出现特定小 TBI 模式且受伤后 24 小时扫描稳定的患者随机分为接受依诺肝素 30mg bid 或安慰剂治疗，从受伤后 24 小时至 96 小时进行双盲治疗。所有患者在开始治疗后 24 小时（即受伤后 48 小时）进行额外的计算机断层扫描。主要终点是 TBI 的影像学加重；次要终点是静脉血栓栓塞的发生和颅外出血并发症。
在 28 个中心月期间，共筛选了 683 例连续 TBI 患者。最常见的排除标准是损伤大于规定标准（n = 199）和受伤前使用抗凝剂（n = 138）。62 例患者被随机分配至依诺肝素（n = 34）或安慰剂（n = 28）组。在受伤后 48 小时和开始治疗后 24 小时进行的扫描中，亚临床、影像学 TBI 进展率分别为依诺肝素组 5.9%（95%置信区间[CI]，0.7-19.7%）和安慰剂组 3.6%（95%CI，0.1-18.3%），治疗效果差异为 2.3%（95%CI，-14.42-16.5%）。无临床 TBI 进展发生。安慰剂组发生 1 例深静脉血栓形成。
在受伤后 24 小时开始依诺肝素治疗小而稳定的损伤后，TBI 进展率与安慰剂相似，且为亚临床进展。下一项 Delayed Versus Early Enoxaparin Prophylaxis 研究将评估在低风险手臂的有力研究中以及在中度风险手臂的 72 小时时间点的安全性试验中这种治疗方法的有效性。
治疗研究，二级。
