Hemostasis, Surgical

止血,外科
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    文章类型: Journal Article
    背景:剖宫产(CD)是全球最常见的手术之一,随着年增长率的增加。尽管神经轴技术仍然是CD的首选麻醉方法,孕产妇血小板减少症仍然是一个突出的禁忌症.脊髓\硬膜外血肿的形成极为罕见,然而,安全的神经轴麻醉所需的最小血小板计数仍在争论中。尽管仍不建议为神经轴麻醉目的输注血小板,重度血小板减少症(<50×103/uL)患者接受血小板输注手术止血。
    目的:对接受血小板输注的重度血小板减少症产妇进行剖腹产的麻醉方法进行评估,以改善手术止血。
    方法:我们进行了一个中心,回顾性队列研究。结果:共发现5例,其中四例在输注血小板后立即给予脊髓麻醉.一名患者因输血后血小板计数未能达到安全水平而被拒绝脊髓麻醉。我们的病例都没有记录到麻醉相关的并发症。
    结论:我们检查了需要剖宫产并输注血小板进行手术止血的重度血小板减少症产妇的麻醉管理。在这种情况下,由于与全身麻醉相关的严重风险,可以考虑脊髓麻醉。
    BACKGROUND: Cesarean delivery (CD) is one of the most common surgeries performed worldwide, with increasing yearly rates. Although neuraxial techniques remain the preferred anesthesia method for CD, maternal thrombocytopenia remains a prominent contraindication. Formation of spinal\\epidural hematomas are extremely rare, however the minimal thrombocyte count required for safe neuraxial anesthesia is still under debate. Although transfusion of thrombocytes for the purpose of neuraxial anesthesia is still not recommended, patients with severe thrombocytopenia (less than 50 × 103/uL) are given thrombocyte transfusion for surgical hemostasis.
    OBJECTIVE: To evaluate the anesthetic approach to caesarean deliveries in parturients with severe thrombocytopenia who received thrombocyte transfusion aimed for improved surgical hemostasis.
    METHODS: We conducted a single center, retrospective cohort study. Results: A total of five cases were found, four of which were given spinal anesthesia immediately following thrombocyte transfusion. One patient was denied spinal anesthesia because her thrombocyte count following transfusion failed to reach safe levels. None of our cases had anesthesia-related complications recorded.
    CONCLUSIONS: We examined the anesthetic management parturients with severe thrombocytopenia who needed cesarean delivery and were transfused with thrombocytes for surgical hemostasis. In such cases, spinal anesthesia may be considered due to the serious risks associated with general anesthesia.
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  • 文章类型: Journal Article
    背景:超声手术刀在手术过程中被广泛使用。据报道,使用超声能量装置关闭7毫米或以下的肺动脉分支血管是安全有效的。然而,目前尚无多中心随机临床试验来评估在胸部手术中使用超声手术刀凝固5-7mm血管的安全性和有效性.
    方法:这是一个前瞻性的,多中心,随机化,并行控制,非劣效性临床试验。总共144名计划接受肺或食道手术的合格患者将被随机分配到实验组和对照组。研究产品(ReachSurgical制造的一次性超声波剪,Inc.)和对照产品(谐波Ace+7,具有高级止血功能的5mm直径剪板机)将用于每组。主要终点是手术期间凝固目标血管的成功率。次要终点包括术后再出血,术中出血量,排水量,手术时间,等。将在出院前后进行术后随访。
    结论:该临床试验旨在评估使用研究产品的安全性和有效性(ReachSurgical制造的一次性超声剪,Inc.)和对照产品(HarmonicAce7,具有高级止血功能的5mm直径剪)在胸外科手术中凝结5-7mm血管。
    背景:ClinicalTrials.gov:NCT06002737。该试验于2023年8月16日注册,https://www。
    结果:gov/study/NCT06002737。
    BACKGROUND: The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5-7 mm blood vessels in thoracic surgery.
    METHODS: This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed.
    CONCLUSIONS: This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5-7 mm blood vessels in thoracic surgery.
    BACKGROUND: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www.
    RESULTS: gov/study/NCT06002737 .
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  • 文章类型: Journal Article
    目的:评估基于膀胱冲洗液颜色的选择性双极等离子技术在HoLEP手术中止血的有效性方法:纳入2021年10月至2023年7月接受HoLEP手术的209例患者,分为止血管理组和对照组。冲洗液的颜色分为5级,当颜色达到4级或更高时,应用双极等离子技术。以下进行分析:术后使用球囊压迫,失血,灌溉时间,住院时间,和第二次操作的次数。
    结果:止血管理组仅有4例患者需要术后导尿管球囊压迫,而对照组有15个(p=0.03)。HM组采用双极等离子止血的患者平均冲洗时间为21.88±13.76小时,与导管球囊压缩患者相比(p=0.007)。
    结论:根据膀胱冲洗比色表,选择性应用双极等离子止血导致术后需要膀胱导管球囊压迫的患者数量显著减少.其次,接受双极等离子止血的患者的冲洗时间也减少了。
    OBJECTIVE: To evaluate the effectiveness of selective bipolar plasmakinetic technology based on bladder irrigation fluid color on hemostasis in HoLEP surgwery METHODS: A total of 209 patients who underwent HoLEP surgery from October 2021 to July 2023 were included and divided into Hemostasis Management Group and control group. the color of the irrigation fluid was categorized into 5 levels and the bipolar plasmakinetic technology was applied when the color came to level 4 or up. The following was analyzed: postoperative use of balloon compression, blood loss, irrigation time, length of hospital stay, and the number of a second operation.
    RESULTS: Only 4 patients in Hemostasis Management Group required postoperative urinary catheter balloon compression, while there are 15 in the control group(p=0.03). The average irrigation time for patients in the HM Group with bipolar plasmakinetic hemostasis was 21.88±13.76 hours, compared to that in patients with catheter balloon compression(p=0.007).
    CONCLUSIONS: Based on the bladder irrigation color chart, the selective application of bipolar plasmakinetic hemostasis led to a significant reduction in the number of patients requiring postoperative bladder catheter balloon compression. Secondly, the irrigation time of patients who underwent bipolar plasmakinetic hemostasis also decreased.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    与MedtronicTri-stepleTM相关的止血相关并发症预装支撑材料和新颖的,裸AEONTM胃肠吻合器尚未在减肥手术中得到广泛研究。该研究旨在评估和比较MedtronicTri-stepleTM和AEONTMGIA吻合器之间30天止血相关并发症。
    对2021年11月至2022年12月在澳大利亚一家私立医院接受原发性或翻修袖状胃切除术(SG)或单吻合口十二指肠回肠旁路手术(SADI-S)的患者的数据进行了回顾性分析。手术由一名外科医生完成,使用美敦力三订书机或AEONTM订书机。
    分析包括250名患者,前125例患者使用MedtronicTri-stepleTMGIA吻合器接受钉线,随后125例患者使用AEONTMGIA吻合器接受钉线。统计分析显示,Medtronic和AEON组之间的外科手术分布没有显着差异。在AEON组,从统计学上讲,糖尿病患者和以前的烟草使用者人数更高,而其他术前特征两组间无显著差异.AEON组的平均手术时间明显更长,而住院时间明显缩短。无术中或30天并发症,死亡,急诊室探视,再入院,两组均观察到或再次手术。
    小说,在减肥手术中,裸AEONTM吻合器在实现止血和保持固定线完整性方面,与已建立的带有预装支撑材料的MedtronicTri-StapleTM相比,具有不劣性。
    UNASSIGNED: Haemostasis-related complications associated with Medtronic Tri-stapleTM with preloaded buttress material and the novel, naked AEONTM gastrointestinal staplers have not been extensively studied in bariatric surgery. The study aimed to assess and compare the 30-day haemostasis-related complications between Medtronic Tri-stapleTM and AEONTM GIA staplers.
    UNASSIGNED: A retrospective analysis was performed on data from patients who underwent primary or revision sleeve gastrectomy (SG) or the sleeve component of single anastomosis duodeno-ileal bypass with SG (SADI-S) in a private hospital in Australia between November 2021 and December 2022. The surgeries were performed by a single surgeon, using either Medtronic Tri-stapleTM or AEONTM staplers.
    UNASSIGNED: The analysis included 250 patients, with the first 125 consecutive patients receiving staple line using the Medtronic Tri-stapleTM GIA stapler and the subsequent 125 patients receiving staple line using the AEONTM GIA stapler. Statistical analysis revealed no significant differences in the distribution of surgical procedures between the Medtronic and AEON groups. In the AEON group, there were statistically higher numbers of diabetics and former tobacco users, while other preoperative characteristics did not significantly differ between the two groups. The AEON group had a significantly longer mean operative time, while the length of hospital stay was significantly shorter. No intraoperative or 30-day complications, deaths, emergency room visits, readmissions, or reoperations were observed in either group.
    UNASSIGNED: The novel, naked AEONTM stapler demonstrated non-inferiority to the established Medtronic Tri-StapleTM with preloaded buttress material in achieving hemostasis and maintaining staple-line integrity in bariatric surgery.
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  • 文章类型: Journal Article
    电外科和超声装置在外科手术中用于血管组织的止血密封和平分。先前的台式研究也证明了成功的红外激光密封和切割血管,在一个连续的,两步法。这项研究描述了一个较小的,腹腔镜设备兼容设计,同时封闭和平分血管,具有潜在的光学反馈。1470nm红外二极管激光器密封并平分了40条猪肾动脉,离体。一个往复的,侧面发射,光纤,装在一个透明的方形石英光学室(2.7×2.7×25毫米的外部尺寸),在11毫米的扫描长度上传递激光能量,具有一定范围的入射功率(41-59W)和治疗时间(5-21s)。容器直径范围为2.5至4.8mm。在每个切割端(n=80)进行容器破裂压力测量,成功的压力超过360mmHg。成功地密封并平分(80/80)所有容器端。最高的入射功率,59W,产生5-6s的短处理时间。外室表面的峰值温度达到103oC。冷却到体温的时间测量为37秒。红外激光同时密封和平分血管,与治疗时间相当,温度和冷却时间低于传统设备的报告。未来的工作将集中在将纤维和腔室集成到标准的5毫米外径腹腔镜设备中。定制光纤扫描长度以匹配血管尺寸还可以减少激光能量沉积,实现较低的峰值温度,治疗次数,和冷却时间。
    Electrosurgical and ultrasonic devices are used in surgical procedures for hemostatic sealing and bisection of vascular tissues. Previous benchtop studies alternatively demonstrated successful infrared laser sealing and cutting of blood vessels, in a sequential, two-step approach. This study describes a smaller, laparoscopic device compatible design, and simultaneous approach to sealing and bisection of vessels, with potential optical feedback. A 1470-nm infrared diode laser sealed and bisected 40 porcine renal arteries, ex vivo. A reciprocating, side-firing, optical fiber, housed in a transparent square quartz optical chamber (2.7 × 2.7 × 25 mm outer dimensions), delivered laser energy over an 11 mm scan length, with a range of incident powers (41-59 W) and treatment times (5-21 s). Vessel diameters ranged from 2.5 to 4.8 mm. Vessel burst pressure measurements were performed on each cut end (n = 80) with success indicated by pressures exceeding 360 mmHg. All vessel ends were successfully sealed and bisected (80/80). The highest incident power, 59 W, yielded short treatment times of 5-6 s. Peak temperatures on the external chamber surface reached 103 oC. Time to cool down to body temperature measured 37 s. Infrared lasers simultaneously seal and bisect blood vessels, with treatment times comparable to, and temperatures and cooling times lower than reported for conventional devices. Future work will focus on integrating the fiber and chamber into a standard 5-mm-outer-diameter laparoscopic device. Customization of fiber scan length to match vessel size may also reduce laser energy deposition, enabling lower peak temperatures, treatment times, and cooling times.
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  • 文章类型: Journal Article
    背景:在急性胆囊炎的腹腔镜胆囊切除术中,由于与炎症相关的组织脆性和易出血,通常很难保持手术视野干燥。由此导致的手术视野不足可导致胆管或血管损伤。软凝血系统用于在各种手术中实现止血;然而,软凝在腹腔镜胆囊切除术治疗急性胆囊炎的有效性尚不清楚.在此过程中,我们证明了钝性解剖和软凝固的有效性和可行性。
    方法:在对2例急性胆囊炎患者进行腹腔镜胆囊切除术时,我们使用钝性解剖和软凝。与传统的腹腔镜胆囊切除术一样,插入了四个端口。用电灼术切断浆膜后,使用软凝固进行钝性解剖,暴露内部浆膜下。使用具有软凝结的钝性解剖保持该层实现了足够清晰的安全视野。切除胆囊动脉和导管后,胆囊床也通过软凝固钝性解剖进行解剖。两名患者的失血量均<20mL。
    结论:在腹腔镜胆囊切除术治疗急性胆囊炎的过程中,用软凝进行钝性解剖可能是保持手术视野干燥和减少失血的有用和可行的方法。
    BACKGROUND: During laparoscopic cholecystectomy for acute cholecystitis, it is often difficult to keep the surgical view dry because of inflammation-related tissue fragility and susceptibility to bleeding. The resulting inadequate surgical view can lead to bile duct or vascular injury. Soft coagulation systems are used to achieve hemostasis during various surgeries; however, the usefulness of soft coagulation during laparoscopic cholecystectomy for acute cholecystitis is unclear. We here demonstrate the usefulness and feasibility of blunt dissection and soft coagulation during this procedure.
    METHODS: We used blunt dissection and soft coagulation when performing laparoscopic cholecystectomy on two patients with acute cholecystitis. As with conventional laparoscopic cholecystectomy, four ports were inserted. After cutting the serosa by electrocautery, blunt dissection using soft coagulation was performed, exposing the inner subserosa. Maintaining this layer using blunt dissection with soft coagulation achieved a sufficiently clear view for safety. After resecting the cystic artery and duct, the gallbladder bed was also dissected by blunt dissection with soft coagulation. Blood loss was <20 mL in both patients.
    CONCLUSIONS: Blunt dissection with soft coagulation may be a useful and feasible means of keeping the surgical view dry and minimizing blood loss during laparoscopic cholecystectomy for acute cholecystitis.
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  • 文章类型: Systematic Review
    背景:在血管介入治疗期间,连接动脉的连接,静脉,或合成移植物,被称为“吻合”,可能是必要的。血管吻合可以从由吻合产生的针孔中出血。各种手术选择可用于实现止血,或者止血,包括将密封剂直接应用到出血的血管或组织上。当常规干预无效时,密封剂设计用于血管手术中作为辅助手段,并由外科医生直接应用于密封出血吻合。尽管有几种不同类型的密封剂,这些止血辅助药物在血管外科患者中的临床疗效尚不明确.
    目的:评估封闭剂作为血管手术患者吻合口止血的辅助手段的益处和危害。
    方法:Cochrane血管信息专家对以下数据库进行了系统搜索:通过Cochrane研究注册的Cochrane血管专业注册;Cochrane对照试验中央注册(CENTRAL);通过Ovid的MEDLINE;通过Ovid的Embase;通过EBSCO的NAHL。我们还搜索了ClinicalTrials.gov和WHO国际临床试验注册平台进行临床试验。还检索了纳入试验的参考文献列表和相关综述。最近的搜索日期是2023年3月6日。
    方法:我们纳入了随机对照试验,将纤维蛋白或合成密封剂的使用与替代干预措施(例如手动压缩,抗凝逆转),以在血管外科手术中实现吻合口部位止血。我们包括在血管手术期间进行吻合的参与者。我们排除了非血管手术患者。
    方法:我们使用了标准的Cochrane方法。我们的主要结果是止血时间,止血干预失败,术中失血。我们的次要结果是手术时间,出血并发症死亡长达30天,术后出血长达30天,计划外返回手术室进行出血并发症管理长达30天,生活质量,和不良事件。我们使用等级来评估每个结果的证据的确定性。
    结果:我们发现了24项随机对照试验,共包括2376名符合纳入标准的参与者。所有试验都将密封剂的使用与标准护理对照进行了比较,包括氧化纤维素,明胶海绵,和手动压缩。所有试验都存在性能偏差的高风险,检测偏差,和其他偏见的来源。我们降低了偏见风险的证据确定性,不一致,不精确和可能的出版偏见。结合止血时间的数据表明,与对照组相比,密封剂的使用可能会减少平均止血时间(平均差异(MD)-230.09秒,95%置信区间(CI)-329.24至-130.94;P<0.00001;7项研究,498名参与者;低确定性证据)。结合止血干预失败的数据表明,与对照组相比,使用密封剂可以降低失败率。但证据非常不确定(风险比(RR)0.46,95%CI0.35至0.61;P<0.00001;17项研究,2120名参与者;非常低的确定性证据)。我们没有发现密封剂组和对照组在术中失血方面的任何明显差异(MD-32.69mL,95%CI-96.21至30.83;P=0.31;3项研究,266名参与者;低确定性证据);手术时间(MD-18.72分钟,95%CI-40.18至2.73;P=0.09;4项研究,436名参与者;低确定性证据);术后出血(RR0.78,95%CI0.59至1.04;P=0.09;9项研究,1216名参与者;低确定性证据),或计划外返回手术室(RR0.27,95%CI0.04至1.69;P=0.16;8项研究,721名参与者;低确定性证据)。没有研究报告出血死亡或生活质量结果。
    结论:基于对2376名参与者的24项试验的荟萃分析,我们的审查表明,在血管手术患者中使用密封剂实现吻合口止血可能导致止血时间减少,并可能降低止血干预失败的发生率,虽然证据很不确定,与标准对照相比。我们的分析显示术中失血量可能没有差异,操作时间,术后出血长达30天,和计划外返回手术室出血并发症长达30天。无法分析死亡和生活质量。限制包括所有研究中的偏倚风险。我们的审查表明,使用密封剂可以减少止血所需的时间和止血失败率。然而,在纳入的研究中发现了显著的偏倚风险,和未来的试验需要提供无偏见的数据,并解决其他考虑因素,如成本效益和使用密封剂的不良事件.
    During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an \'anastomosis\', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients.
    To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery.
    The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023.
    We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients.
    We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome.
    We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes.
    Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.
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  • 文章类型: Journal Article
    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)。
    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).
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  • 文章类型: Journal Article
    背景:普通外科医师在腹部手术期间使用止血剂是一种常见的辅助措施,以最大程度地减少术后出血及其下游并发症的风险。对产品的正确选择可能会受到对其药代动力学和药效学的边际理解的阻碍。虽然目前市场上有多种止血剂,这些产品的选择通常会让外科医生感到困惑。本文旨在总结和比较每种临床适应症可用的止血产品,最终更好地指导外科医生在日常临床实践中选择和正确使用止血剂。
    方法:我们利用PubMed电子数据库和各自制药公司发布的产品信息来收集有关止血产品特性的信息。
    结果:美国所有市售的止血剂均描述了其作用机理,适应症,禁忌症,它们得到最好利用的情况,和预期的结果。
    结论:止血产品有许多不同的类型和规格。它们是作为手术止血的辅助手段的有价值的工具。正确的教育和对其特征的了解对于选择正确的代理和最佳利用至关重要。
    BACKGROUND: The use of hemostatic agents by general surgeons during abdominal operations is commonplace as an adjunctive measure to minimize risks of postoperative bleeding and its downstream complications. Proper selection of products can be hampered by marginal understanding of their pharmacokinetics and pharmacodynamics. While a variety of hemostatic agents are currently available on the market, the choice of those products is often confusing for surgeons. This paper aims to summarize and compare the available hemostatic products for each clinical indication and to ultimately better guide surgeons in the selection and proper use of hemostatic agents in daily clinical practice.
    METHODS: We utilized PubMed electronic database and published product information from the respective pharmaceutical companies to collect information on the characteristics of the hemostatic products.
    RESULTS: All commercially available hemostatic agents in the US are described with a description of their mechanism of action, indications, contraindications, circumstances in which they are best utilized, and expected results.
    CONCLUSIONS: Hemostatic products come with many different types and specifications. They are valuable tools to serve as an adjunct to surgical hemostasis. Proper education and knowledge of their characteristics are important for the selection of the right agent and optimal utilization.
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