Abstract：
BACKGROUND: Intraoperative blood loss and postoperative hemorrhage affect outcomes after liver resection. GATT-Patch is a new flexible, pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with N-hydroxy-succinimide polyoxazoline. We evaluated safety and performance of the GATT-Patch for hemostasis at the liver resection plane.
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).
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).
摘要：
背景：术中失血和术后出血影响肝切除术后的预后。关贸总协定补丁是一个新的灵活，包括用N-羟基-琥珀酰亚胺聚恶唑啉浸渍的纤维明胶载体的柔韧止血密封剂贴片。我们评估了GATT-贴片在肝切除平面止血的安全性和性能。
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）。
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）。
