tranexamic acid

氨甲环酸
  • 文章类型: Case Reports
    纤溶和凝血功能亢进被证明在慢性硬膜下血肿(CSDH)的液化和进展中起作用。氨甲环酸是正在探索的药物选择之一,因为它抑制了高纤维蛋白溶解活性并降低了CSDH中的血管通透性,导致血肿逐渐消退。在这个案例研究中,我们介绍了一例86岁合并并发症患者使用氨甲环酸进行CSDH治疗的病例.在这种情况下,使用氨甲环酸后血肿的完全缓解,在两年的随访中没有复发史,支持其在CSDH治疗中的疗效,并且可以被认为是有助于预防手术的策略之一。
    Fibrinolytic and coagulative hyperactivity is proven to have a role in liquefaction and progression of chronic subdural hematoma (CSDH). Tranexamic acid was one of the pharmaceutical options that was explored, as it inhibits the hyper-fibrinolytic activity and reduces the vascular permeability in CSDH, leading to a gradual resolution of the hematoma. In this case study, we present a case of using tranexamic acid for CSDH treatment in an 86-year-old patient with co-morbidities. The complete resolution of the hematoma following using tranexamic acid in this case with no history of recurrence in two years follow-up supports its efficacy in CSDH treatment and may be considered as one of the strategies that help prevent surgeries.
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  • 文章类型: Journal Article
    鼻部手术(例如:鼻整复术,鼻中隔成形术)和鼻窦手术(例如:功能性内窥镜鼻窦手术)是耳鼻咽喉科的常见程序。氨甲环酸(TXA),一种抗纤维蛋白溶解药物,最近越来越多地用于减少出血。虽然在解剖学上很接近,鼻窦和鼻部手术的出血性质可能不同。我们提出了第一个荟萃分析,该分析对鼻腔和鼻窦手术进行了综合回顾,并对两者进行了比较。Pubmed,Embase,搜索CochraneLibrary和WoS直到2023年4月。感兴趣的结果包括Boezart评分,凝血时间,术后并发症和手术野质量。评估了27项研究,其中25项研究进行了定量评估。在27项研究中,15项研究涉及鼻窦手术,而12项研究涉及鼻部手术。氨甲环酸的使用在失血评估中特别有益,减少操作时间,手术野质量和外科医生满意度。TXA已被证明在不同程度上在鼻和鼻窦手术中均有效。与鼻部手术相比,TXA在鼻窦手术中具有更多的效果,如减少失血量和手术时间等客观指标,但对于主观标记,如外科医生满意度评分,则相反。
    在线版本包含补充材料,可在10.1007/s12070-024-04579-x获得。
    Nasal surgeries (e.g.: rhinoplasties, septoplasties) and sinus surgeries (e.g.: Functional Endoscopic Sinus Surgeries) are common procedures in Otorhinolaryngology. Tranexamic acid (TXA), an antifibrinolytic drug, has been increasingly utilized to reduce hemorrhage recently. While close in proximity anatomically, the bleeding nature of sinus and nasal surgeries may differ. We present the first meta-analysis that has reviewed both nasal and sinus surgery collectively and compares the two. Pubmed, Embase, Cochrane Library and WoS were searched until April 2023. Outcomes of interest include Boezart Scoring, clotting time, postoperative complications and surgical field quality. 27 Studies were assessed, of which 25 studies were evaluated quantitatively. Of the 27 studies, 15 studies involved Sinus surgery while 12 involved Nasal surgery. The use of tranexamic acid was notably beneficial in the evaluation of blood loss, reduction of operating time, surgical field quality and surgeon satisfaction. TXA has proven to be efficacious in both nasal and sinus surgeries to varying degrees. TXA has more effects in sinus surgeries compared to nasal surgeries in objective markers such as reducing blood loss and operating time, but the converse occurs for subjective markers such as surgeon satisfaction scores.
    UNASSIGNED: The online version contains supplementary material available at 10.1007/s12070-024-04579-x.
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  • 文章类型: Journal Article
    本研究旨在评估氨甲环酸(TXA)在预防产后出血(PPH)的效果,这些产后出血(PPH)的风险因素已确定在中国进行阴道分娩的妇女。
    这个前景,随机化,开放标签,盲法终点(PROBE)试验纳入了2258名接受阴道分娩的具有一种或多种PPH危险因素的女性.参与者以1:1的比例随机分配,在婴儿分娩后立即接受1gTXA或安慰剂的血管内输注。评估的主要结果是PPH的发生率,定义为分娩后24小时内失血≥500mL,而重度PPH被认为是次要结局,并定义为24小时内总失血≥1000mL。
    2245个人(99.4%)可以随访他们的主要结果。TXA组1128名妇女中有186名发生PPH,安慰剂组1117名妇女中有215名发生PPH(16.5%vs.19.2%;RR,0.86;95%CI,0.72至1.02;p=0.088)。关于与疗效相关的次要结果,TXA组的女性重度PPH的发生率明显低于安慰剂组(2.7%vs.5.6%;RR,0.49;95%CI,0.32至0.74;p=0.001;调整后p=0.002)。同样,使用额外的子宫收缩剂显著减少(7.8%vs.15.6%;RR,0.50;95%CI,0.39至0.63;p<0.001;调整后p=0.001)。两组在分娩后30天内均未发生血栓栓塞事件和孕产妇死亡。
    在有PPH危险因素的总人口中,与安慰剂相比,阴道分娩后给予TXA并未导致PPH发生率的统计学显著降低;它与重度PPH的发生率显著降低相关.
    在阴道分娩中有危险因素的妇女中,预防性给予TXA并没有显著降低PPH的发生率。预防性使用TXA可能有助于降低严重PPH的发生率。
    UNASSIGNED: This study aimed to evaluate the effects of tranexamic acid (TXA) in preventing postpartum haemorrhage (PPH) among women with identified risk factors for PPH undergoing vaginal delivery in China.
    UNASSIGNED: This prospective, randomized, open-label, blinded endpoint (PROBE) trial enrolled 2258 women with one or more risk factors for PPH who underwent vaginal delivery. Participants were randomly assigned in a 1:1 ratio to receive an intravascular infusion of 1 g TXA or a placebo immediately after the delivery of the infant. The primary outcome assessed was the incidence of PPH, defined as blood loss ≥500 mL within 24 h after delivery, while severe PPH was considered as a secondary outcome and defined by total blood loss ≥1000 mL within 24 h.
    UNASSIGNED: 2245 individuals (99.4%) could be followed up to their primary outcome. PPH occurred in 186 of 1128 women in the TXA group and in 215 of 1117 women in the placebo group (16.5% vs. 19.2%; RR, 0.86; 95% CI, 0.72 to 1.02; p = 0.088). Regarding secondary outcomes related to efficacy, women in the TXA group had a significant lower rate of severe PPH than those in the placebo group (2.7% vs. 5.6%; RR, 0.49; 95% CI, 0.32 to 0.74; p = 0.001; adjusted p = 0.002). Similarly, there was a significant reduction in the use of additional uterotonic agents (7.8% vs. 15.6%; RR, 0.50; 95% CI, 0.39 to 0.63; p < 0.001; adjusted p = 0.001). No occurrence of thromboembolic events and maternal deaths were reported in both groups within 30 days after delivery.
    UNASSIGNED: In total population with risk factors for PPH, the administration of TXA following vaginal delivery did not result in a statistically significant reduction in the incidence of PPH compared to placebo; however, it was associated with a significantly lower incidence of severe PPH.
    Prophylactic administration of TXA did not yield a statistically significant reduction in the incidence of PPH among women with risk factors in vaginal deliveries.Prophylactic use of TXA may help to reduce the incidence of severe PPH.
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  • 文章类型: Journal Article
    背景:老年髋部骨折与高致残率和死亡率相关。这些患者中的许多需要围手术期和术后的同种异体输血,这带来了几个值得注意的风险。越来越多的文献支持氨甲环酸(TXA)在老年髋部骨折中的疗效,没有足够的数据检查哪些亚组可能受益最大。
    方法:在本研究中,我们试图评估TXA是否与在我们机构接受髋部骨折内固定术的老年患者失血量和输血量减少相关.在引入质量控制计划之前,以回顾性方式收集了第一年的数据,该计划鼓励对所有老年髋部骨折进行TXA管理。第二年的数据是前瞻性收集的。对接受关节置换术的患者进行了亚组分析。
    结果:在合并的手术患者队列中,TXA在减少失血或输血需求方面与对照组相比没有益处。然而,接受关节成形术的患者亚组显示,住院期间总失血量和总输血单位量显著减少.
    结论:这些结果表明,当针对老年髋部骨折进行关节置换术时,TXA可能是最有益的。
    BACKGROUND: Geriatric hip fractures are associated with high rates of disability and mortality. Many of these patients require perioperative and postoperative allogeneic blood transfusions, which carry several noteworthy risks. A growing body of literature supports the efficacy of tranexamic acid (TXA) in geriatric hip fractures, without sufficient data examining which subgroups are likely to benefit the most.
    METHODS: In this study, we sought to evaluate whether TXA was associated with reduced blood loss and transfusions in a geriatric population undergoing hip fracture fixation at our institution during a 2-year period. The first year\'s data were collected in a retrospective fashion before the introduction of a quality control initiative encouraging TXA administration for all geriatric hip fractures. The second year\'s data were collected prospectively. A subgroup analysis was conducted for patients who underwent arthroplasties.
    RESULTS: Among the pooled cohort of patients undergoing surgery, TXA showed no benefit over control subjects for reducing blood loss or transfusion requirements. However, the subgroup of patients undergoing arthroplasty procedures showed a notable decrease in total blood loss and total units transfused during hospitalization.
    CONCLUSIONS: These results suggest that TXA may be most beneficial when targeted to arthroplasties performed for geriatric hip fractures.
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  • 文章类型: Journal Article
    背景:抗凝药物是降低高危患者血栓形成风险的有价值的工具。这项研究的目的是进行文献综述,强调在日常临床牙科实践中这些药物的管理。
    方法:我们的搜索仅限于1989年1月1日至2024年3月7日在PubMed发表的英文论文,Scopus和WebofScience与我们的主题相关。在搜索方法中,使用布尔关键字“抗凝剂和牙科”。
    结果:从数据库WebofScience(83)获得的623篇文章中纳入了25项临床试验进行最终审查。PubMed(382),Scopus(158)消除重复项和79个偏离主题的项目,删除315个条目并确认合格后,生成419篇文章。总的来说,这些研究支持使用局部止血措施来控制接受抗凝治疗的牙科手术患者的出血风险,并强调了加强医疗保健专业人员教育和合作的重要性.
    结论:研究和临床调查改善了接受抗凝或抗血小板治疗的患者对牙科手术的理解和管理。止血剂,临床方案,危险因素,持续教育对于应对抗凝治疗的复杂性至关重要,确保最佳结果并增强患者的健康。
    BACKGROUND: Anticoagulant drugs are a valuable tool for minimizing thrombotic risks in at-risk patients. The purpose of this study is to conduct a literature review highlighting the management of these drugs during daily clinical dental practice.
    METHODS: We limited our search to English-language papers published between 1 January 1989, and 7 March 2024, in PubMed, Scopus and Web of Science that were relevant to our topic. In the search approach, the Boolean keywords \"anticoagulant AND dentistry\" were used.
    RESULTS: Twenty-five clinical trials were included for final review from 623 articles obtained from the databases Web of Science (83), PubMed (382), and Scopus (158), eliminating duplicates and 79 off-topic items, resulting in 419 articles after removing 315 entries and confirming eligibility. Overall, these studies support the use of local hemostatic measures to manage the risk of bleeding in patients on anticoagulant therapy undergoing dental procedures and highlight the importance of greater education and collaboration among healthcare professionals.
    CONCLUSIONS: Research and clinical investigation have improved understanding and management of dental procedures in patients undergoing anticoagulant or antiplatelet therapy. Hemostatic agents, clinical protocols, risk factors, and continuous education are essential for navigating the complexities of anticoagulant therapy, ensuring optimal outcomes and enhancing patient well-being.
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  • 文章类型: Journal Article
    本研究旨在研究口服氨甲环酸(TXA)对减少脊柱手术中术中出血的影响。
    这项研究是一个单中心,双盲,随机化,安慰剂对照临床试验。参与者是20岁以上接受脊柱手术的个体。患者口服1.5gTXA,手术前2h。术中出血量,手术后引流管的血容量,手术后住院时间,恶心或呕吐的发生率,血红蛋白(Hb)水平降低,并对各组术后凝血检测结果进行评价。
    在这项研究中,根据纳入和排除标准将患者分配到每个研究组.患者平均年龄为69.6±6.47岁,65%是男性。在年龄上没有显著差异,性别,术前术后Hb水平,凝血酶原时间(PT),或研究组之间的国际标准化比率(INR)。TXA组术中出血量和术后引流管的血容量明显降低。此外,TXA组术后住院时间明显缩短.TXA组恶心或呕吐的发生率明显较高。此外,TXA组术后部分凝血活酶时间(PTT)明显高于安慰剂组.
    脊柱手术前口服TXA可显著减少术中和术后出血,且无明显不良反应,还可缩短住院时间。
    UNASSIGNED: This study aimed to investigate the effect of oral administration of tranexamic acid (TXA) on reducing intraoperative bleeding during spinal surgeries.
    UNASSIGNED: The study was a single-center, double-blind, randomized, placebo-controlled clinical trial. Participants were individuals over 20 years old who underwent spinal surgery. Patients received 1.5 g of TXA orally, 2 h before surgery. Intraoperative bleeding volume, blood volume in the drain after surgery, length of hospital stays after surgery, incidence of nausea or vomiting, decrease in hemoglobin (Hb) level, and postoperative coagulation test results were evaluated in each group.
    UNASSIGNED: In this study, patients were assigned to each study group based on inclusion and exclusion criteria. The mean age of patients was 69.6±6.47 years, and 65% were male. There was no significant difference in age, sex, pre and postoperative Hb levels, prothrombin time (PT), or international normalized ratio (INR) between the study groups. Intraoperative bleeding volume and blood volume in the drain after surgery were significantly lower in the TXA group. Additionally, the length of hospital stay after surgery was significantly shorter in the TXA group. The incidence of nausea or vomiting was significantly higher in the TXA group. Furthermore, postoperative partial thromboplastin time (PTT) was significantly higher in the TXA group compared to the placebo group.
    UNASSIGNED: Oral administration of TXA before spinal surgery leads to a significant reduction in intraoperative and postoperative bleeding without significant adverse effects and also reduces the length of hospital stay.
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  • 文章类型: Journal Article
    目的:根治性膀胱切除术与出血和高输血率相关,患者管理面临挑战。这项研究调查了根治性膀胱切除术中氨甲环酸的预防性使用。
    方法:所有在三级护理大学中心接受根治性膀胱切除术治疗的患者均来自前瞻性维护的数据库。在膀胱切除术方案的制度改变后,患者接受了1g氨甲环酸静脉推注作为预防。为了防止偏见,应用了倾向得分匹配,考虑术前血红蛋白的差异,新辅助化疗,肿瘤分期,和外科医生的经验。主要结果包括输血率,并发症,和静脉血栓栓塞的发生。
    结果:总计,420名患者被纳入分析,其中35人接受了氨甲环酸。在倾向得分匹配后,32例患者和32例对照患者的临床病理特征相匹配。与对照组相比,氨甲环酸显着减少了接受输血的患者数量(19%[95%-置信区间=8.3;37.1]vs.47%[29.8;64.8];p=0.033)。氨甲环酸的术中和术后输血率均较低,虽然没有统计学意义(6%[1.5;23.2]与19%[8.3;37.1],和16%[6.3;33.7]与38%[21.9;56.1];分别为p=0.257和p=0.089)。两组之间静脉血栓栓塞的发生率没有显着差异(9%[2.9;26.7]vs.3%[0.4;20.9];p=0.606)。
    结论:预防性给药,使用简化的术前给药方案1g作为推注,膀胱切除术后输血率显着降低。这项探索性研究表明,氨甲环酸在改善开放性根治性膀胱切除术的预后方面具有潜力。
    OBJECTIVE: Radical cystectomy is associated with bleeding and high transfusion rates, presenting challenges in patient management. This study investigated the prophylactic use of tranexamic acid during radical cystectomy.
    METHODS: All consecutive patients treated with radical cystectomy at a tertiary care university center were included from a prospectively maintained database. After an institutional change in the cystectomy protocol patients received 1 g of intravenous bolus of tranexamic acid as prophylaxis. To prevent bias, propensity score matching was applied, accounting for differences in preoperative hemoglobin, neoadjuvant chemotherapy, tumor stage, and surgeon experience. Key outcomes included transfusion rates, complications, and occurrence of venous thromboembolism.
    RESULTS: In total, 420 patients were included in the analysis, of whom 35 received tranexamic acid. After propensity score matching, 32 patients and 32 controls were matched with regard to clinicopathologic characteristics. Tranexamic acid significantly reduced the number of patients who received transfusions compared to controls (19% [95%-Confidence interval = 8.3; 37.1] vs. 47% [29.8; 64.8]; p = 0.033). Intraoperative and postoperative transfusion rates were lower with tranexamic acid, though not statistically significant (6% [1.5; 23.2] vs. 19% [8.3; 37.1], and 16% [6.3; 33.7] vs. 38% [21.9; 56.1]; p = 0.257 and p = 0.089, respectively). The occurrence of venous thromboembolism did not differ significantly between the groups (9% [2.9; 26.7] vs. 3% [0.4; 20.9]; p = 0.606).
    CONCLUSIONS: Prophylactic tranexamic administration, using a simplified preoperative dosing regimen of 1 g as a bolus, significantly lowered the rate of blood transfusion after cystectomy. This exploratory study indicates the potential of tranexamic acid in enhancing outcomes of open radical cystectomy.
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  • 文章类型: Journal Article
    背景:需要拔牙的华法林患者面临出血的问题,没有足够的止血会导致干窝和术后疼痛。这项研究旨在评估和比较局部应用氨甲环酸浸泡的可吸收明胶(TXA-Gel)和盐水浸泡的可吸收明胶(盐水-Gel)在缓解双侧简单拔除永久性下颌磨牙后的术后疼痛华法林患者。
    方法:这是一个随机的,三盲,裂口,主动对照临床试验。它是在口腔颌面外科进行的,牙科学院,大马士革大学,2021年11月至2023年10月。60颗双侧下颌永久磨牙,在30例华法林患者中,根据提取后使用的局部止血剂随机分为两组:第1组:对照组,盐水凝胶(n=30)。组2:TXA-凝胶(n=30)。通过掷硬币进行简单的随机化方法。主要结果指标是视觉模拟量表(VAS)。在基线(t0)评估疼痛的强度,在1号(t1),第二(t2),3rd(t3),第四(t4),5th(t5),6th(t6),和提取后第7天(t7)。进行了Kolmogorov-Smirnov检验和Mann-WhitneyU检验。显著性水平设定为0.05(p<0.05)。
    结果:在TXA-Gel组中,t1时的平均vas评分为4.17±1.76,在t7时下降至0.73±0.78。然而,在明胶组,t1时平均vas评分为4.83±2.18,t7时下降至1.80±1.00。Mann-WhitneyU检验结果显示,两组在t1(p=0.236)和t2(p=0.155)时差异无统计学意义。然而,其余时间点差异有统计学意义(p<0.05)。
    结论:TXA-Gel在缓解华法林患者拔牙后疼痛方面发挥了重要作用。
    背景:该试验在ISRCTN注册中心(ISRCTN71901901)进行回顾性注册。
    BACKGROUND: Warfarin patients who need dental extraction face the problem of bleeding and no sufficient hemostasis results in dry socket and postoperative pain. This study aimed to evaluate and compare the efficacy of the topical application of tranexamic acid-soaked absorbable Gelfoam (TXA-Gel) and saline-soaked absorbable Gelfoam (saline-Gel) in relieving postoperative pain following bilateral simple extraction of permanent mandibular molars in warfarin patients.
    METHODS: This was a randomized, triple-blinded, split-mouth, active-controlled clinical trial. It was performed at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University, between November 2021 and October 2023. 60 bilateral permanent mandibular molars, which were indicated for simple extraction in 30 warfarin patients randomly assigned into two groups according to the topical hemostatic agents after extraction used: Group 1: control group, saline-Gel (n = 30). Group 2: TXA-Gel (n = 30). A simple randomization method was performed by flipping a coin. The primary outcome measure was the visual analogue scale (VAS). The intensity of pain was evaluated at the baseline (t0), and on the 1st (t1), 2nd (t2), 3rd (t3), 4th (t4), 5th (t5), 6th (t6), and 7th (t7) days following extraction. The Kolmogorov-Smirnov test and the Mann-Whitney U test were performed. The level of significance was set at 0.05 (p < 0.05).
    RESULTS: The mean vas scores was 4.17 ± 1.76 at t1 and decreased to 0.73 ± 0.78 at t7 in the TXA-Gel group. However, in the Gelfoam group, the mean vas scores was 4.83 ± 2.18 at t1 and decreased to 1.80 ± 1.00 at t7. The results of the Mann-Whitney U test showed that there was no statistically significant difference between the two groups at t1 (p = 0.236) and t2 (p = 0.155). However, there was a statistically significance difference at the rest time points (p < 0.05).
    CONCLUSIONS: TXA-Gel played a prominent role in alleviating post-extraction pain in warfarin patients.
    BACKGROUND: The trail was retrospectively registered at the ISRCTN registry (ISRCTN71901901).
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  • 文章类型: Journal Article
    Introduction: Drain placement is commonplace after many plastic surgery procedures to evacuate excess blood and fluid. Tranexamic acid (TXA) is an antifibrinolytic that has been shown to decrease bleeding and fluid production at surgical sites and can be administered orally, intravenously, and topically. The purpose of this study is to evaluate the effect of topical TXA on drain removal in abdominally based autologous breast reconstruction (ABABR). Methods: A retrospective chart review was performed on patients who underwent ABABR from August 2018 to November 2019. In 1 cohort, a 2.5% TXA solution was topically applied to the abdominal wall prior to closure. Drains were removed when output was less than 30 mL/day for 2 consecutive days. The primary outcome was days to drain removal. Secondary outcomes include daily inpatient drain output, postoperative hemoglobin levels, blood transfusions, and complications within 30 days postoperatively. Results: Eighty-three patients were included, with 47 in the control group and 36 in the TXA group. Drains were removed significantly earlier in patients who received TXA (16 days vs 23 days, P = .02). Additionally, significantly fewer patients required postoperative blood transfusions in the TXA group (2 vs 14, P = .005). Abdominal complications were fewer in the TXA group with significantly less wound healing complications (22% vs 49%, P = .01). There was no difference in flap loss or systemic thromboembolic events. Conclusion: Topical TXA use in ABABR results in earlier abdominal drain removal, less blood transfusions, and lower abdominal wound complications without an increased risk of flap loss or adverse patient outcomes.
    Introduction : La mise en place d\'un drain est habituelle après de nombreuses procédures de chirurgie plastique pour l\'évacuation des excès de sang et de liquide. L\'acide tranexamique (TXA) est un agent antifibrinolytique qui a une efficacité démontrée sur la réduction des saignements et de la production de fluides au niveau des sites chirurgicaux; il peut être administré par voie orale, par voie intraveineuse ou en application locale. L\'objectif de cette étude était d\'évaluer l\'effet du TXA topique sur le retrait du drain après reconstruction mammaire autologue à base abdominale (ABABR). Méthodes : Un examen rétrospectif des dossiers des patients ayant subi une ABABR entre août 2018 et novembre 2019 a été effectué. Dans une cohorte, une solution de TXA à 2,5 % a été appliquée localement sur la paroi abdominale avant sa fermeture. Les drains ont été retirés quand la production est devenue inférieure à 30 mL/jour pendant 2 jours consécutifs. Le critère d\'évaluation principal était le nombre de jours jusqu\'au retrait du drain. Les critères de jugement secondaires étaient notamment : la production quotidienne du drain chez les patients hospitalisés, les taux d\'hémoglobine postopératoires, les transfusions sanguines et les complications survenues dans les 30 jours postopératoires. Résultats : Quatre-vingt-trois patients ont été inclus, dont 47 dans le groupe contrôle et 36 dans le groupe TXA. Les drains ont été retirés significativement plus tôt chez les patients qui avaient reçu du TXA (16 jours contre 23 jours, P = 0,02). De plus, un nombre significativement inférieur de patients a nécessité des transfusions sanguines postopératoires dans le groupe TXA (2 contre 14, P = 0,005). Les complications abdominales ont été moins nombreuses dans le groupe TXA avec significativement moins de complications de cicatrisation (22 % contre 49 %, P = 0,01). Il n\'y a pas eu de différence concernant la perte du lambeau cutané ou les événements thromboemboliques systémiques. Conclusion : L\'utilisation topique de TXA dans l\'ABABR permet un retrait plus précoce du drain abdominal, moins de transfusions sanguines et moins de complications de la plaie abdominale inférieure sans augmentation du risque de perte du lambeau cutané ou d\'événements indésirables pour le patient.
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  • 文章类型: Journal Article
    背景:尽管知识有所增加,烧伤切除手术期间的失血量仍然是一项重大挑战,也是死亡率的独立预测指标.在烧伤手术期间,控制出血的措施有限。纤维蛋白溶解增加可能是烧伤切除手术中失血的因素之一。氨甲环酸抑制纤溶反应,少量证据表明氨甲环酸对失血量有积极影响。
    方法:本研究的主要目标是双重的,(1)研究氨甲环酸是否减少失血;(2)研究烧伤创伤后和烧伤切除手术中凝血功能的变化。这项研究是一项针对荷兰烧伤中心计划进行烧伤切除手术的患者的多中心双盲随机临床试验。所有计划进行烧伤手术的预期失血≥250的成年患者均符合纳入本研究的条件。该研究支持干预组减少25%的失血量。总的来说,将包括95个主题。干预组将接受1500mg氨甲环酸,而另一组则接受安慰剂。主要终点是减少失血。次要终点包括手术期间纤维蛋白溶解的发生,裂开的皮肤移植物的移植物,以及凝血和血凝块形成的差异。
    结论:该随机对照试验方案旨在研究氨甲环酸在减少烧伤切除手术中失血的效果。此外,本研究旨在阐明烧伤后和手术过程中的凝血状态。
    背景:EudraCT:2020-005405-10;ClinicalTrial.gov:NCT05507983(于2022年8月回顾性注册,于2021年12月开始纳入)。
    BACKGROUND: Despite an increase in knowledge, blood loss during burn excisional surgery remains a major challenge and is an independent predictor of mortality. During burn surgery, limited measures are available to control the bleeding. Increased fibrinolysis could be one of the contributing factors of blood loss during burn excisional surgery. Tranexamic acid inhibits the fibrinolytic response, and a small body of evidence shows positive effects of tranexamic acid on the volume of blood loss.
    METHODS: The main objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces blood loss and (2) to investigate the changes in coagulation after burn trauma and during burn excisional surgery. This study is a multicenter double-blind randomized clinical trial in patients scheduled for burn excisional surgery within the Dutch burn centers. All adult patients scheduled for burn surgery with an expected blood loss of ≥ 250 are eligible for inclusion in this study. The study is powered on a blood loss reduction of 25% in the intervention group. In total, 95 subjects will be included. The intervention group will receive 1500 mg tranexamic acid versus placebo in the other group. Primary endpoint is reduction of blood loss. Secondary endpoints include occurrence of fibrinolysis during surgery, graft take of the split skin graft, and differences in coagulation and blood clot formation.
    CONCLUSIONS: This protocol of a randomized controlled trial aims to investigate the efficacy of tranexamic acid in reducing blood loss during burn excisional surgery. Furthermore, this study aims to clarify the coagulation status after burn trauma and during the surgical process.
    BACKGROUND: EudraCT: 2020-005405-10; ClinicalTrial.gov: NCT05507983 (retrospectively registered in August 2022, inclusion started in December 2021).
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