Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries.
Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries.
复制标题
DOI：
10.1111/acem.14343
复制
发表时间：
2021-12
期刊：
影响因子：
--
通讯作者：
TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN)
中科院分区：
文献类型：
--
作者：
Linakis SW;Kuppermann N;Stanley RM;Hewes H;Myers S;VanBuren JM;Casper TC;Bobinski M;Ghetti S;Schalick WO 3rd;Nishijima DK;TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN)
联邦知情同意例外（EFIC）程序允许研究在无法获得书面同意的情况下招募患有时间敏感、危及生命的疾病的患者。我们的目的是比较氨甲环酸 (TXA) 用于治疗出血性损伤儿童的试验中使用和不使用 EFIC 的入组率。我们进行了一项四中心随机对照试验和可行性试验，评估 TXA 对患有严重出血性脑部和/或躯干损伤的儿童的作用。我们启动了招募没有 EFIC 的患者的试验。入组 3 个月后，我们达到了先验无效阈值，并暂停了试验以纳入 EFIC 程序并获得监管部门的批准。然后，如果监护人无法及时提供书面同意，我们重新启动试验，允许 EFIC。我们使用描述性统计数据来比较接受和未接受 EFIC 手术的合格患者的特征。我们还使用 EFIC 计算了重新启动试验的时间延迟。在使用 EFIC 程序之前，我们招募了 15 名符合条件的患者中的 1 名 (6.7%)（每个中心每月 0.17 名患者）。在 14 名错过资格的患者中，有 7 名（50%）因监护人不在场或受伤且无法提供书面同意而未入组。在获得 EFIC 批准后，我们招募了 48 名符合条件的患者中的 30 名 (62.5%)（每个中心每月 1.34 名患者）。在这 30 名患者中，22 名 (73.3%) 参加了 EFIC。在 22 人中，随机分组后没有监护人拒绝书面同意。有或没有 EFIC 程序入组的合格率和患者特征没有显着差异。在所有站点中，使用 EFIC 程序重新启动试验的平均延迟为 12 个月。在一项针对重伤儿童的多中心试验中，EFIC程序的使用大大提高了入组率，并受到监护人的广泛接受。在没有 EFIC 程序的情况下启动试验导致了入组的严重延迟。
Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries. We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC. We enrolled 1 of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, 7 (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months. In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.
登录
查看更多内容
影响因子：
3.4
作者：
Sims, Carrie A.;Isserman, Joshua A.;Reilly, Patrick
通讯作者：
Reilly, Patrick
影响因子：
4.4
作者：
Stanley, Rachel M.;Johnson, Michael D.;Kuppermann, Nathan
通讯作者：
Kuppermann, Nathan
影响因子：
6.2
作者：
Wright, David W.;Clark, Pamela L.;Kellermann, Arthur L.
通讯作者：
Kellermann, Arthur L.
影响因子：
120.7
作者：
Chamberlain, James M.;Okada, Pamela;Baren, Jill
通讯作者：
Baren, Jill
DOI：
10.1097/ta.0b013e318165c15c
发表时间：
2008-04-01
影响因子：
--
作者：
Dutton, Richard P.;Stansbury, Lynn G.;Scalea, Thomas M.
通讯作者：
Scalea, Thomas M.