METHODS: Adult patients undergoing elective open liver surgery were recruited in three centers. GATT-Patch was used for minimal to moderate bleeding at the liver resection plane. The primary endpoint was hemostasis of the first-treated bleeding site at 3 min versus a prespecified performance goal of 65.4%.
RESULTS: Two trial stages were performed: I (n = 8) for initial safety and II (n = 39) as the primary outcome cohort. GATT-Patch was applied in 47 patients on 63 bleeding sites. Median age was 60.0 (range 25-80) years and 70% were male. Most (66%) surgeries were for colorectal cancer metastases. The primary endpoint was met in 38 out of 39 patients (97.4%; 95% confidence interval: 84.6%-99.9%) versus 65.4% (P < 0.001). Of all the 63 bleeding sites, hemostasis was 82.7% at 30, 93.7% at 60, and 96.8% at 180 s. No reoperations for rebleeding or device-related issues occurred.
CONCLUSIONS: When compared to a performance goal derived from state-of-the-art hemostatic agents, GATT-Patch for the treatment of minimal to moderate bleeding during liver surgery successfully and quickly achieved hemostasis with acceptable safety outcomes. (ClinicalTrials.gov Identifier: NCT04819945).
方法:在三个中心招募接受选择性开放肝脏手术的成年患者。GATT-Patch用于肝切除平面的最小至中度出血。主要终点是在3分钟时首次治疗出血部位的止血,而预设的表现目标为65.4%。
结果:进行了两个试验阶段:I(n=8)为初始安全性,II(n=39)为主要结局队列。GATT-Patch应用于47例患者的63个出血部位。中位年龄为60.0岁(25-80岁),其中70%为男性。大多数(66%)手术是针对结直肠癌转移。39例患者中有38例(97.4%;95%置信区间:84.6%-99.9%)与65.4%(P<0.001)达到主要终点。在所有63个出血部位中,30时止血率为82.7%,60时止血率为93.7%,180时止血率为96.8%。未发生再出血或器械相关问题的再手术。
结论:当与来自最先进的止血剂的性能目标相比时,GATT-Patch用于治疗肝脏手术期间的轻度至中度出血,成功且快速实现止血,安全性可接受。(ClinicalTrials.gov标识符:NCT04819945)。