Thromboprophylaxis

血栓预防
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    文章类型: Journal Article
    确定静脉血栓栓塞(VTE)的危险因素有助于决定VTE的血栓预防。一项回顾性研究表明,在我们的人群中,高血压和糖尿病与VTE之间存在关联。这项研究的目的是确认这些发现,并确定完整的血细胞计数和凝血测试是否也可以作为对VTE患者进行分层预防的有用参数。
    这是一项性别和年龄匹配的前瞻性病例对照研究,研究对象为45例多普勒证实的DVT和43例明显健康的对照。
    确定的危险因素包括高血压病史,糖尿病,以前的DVT,最近的手术,最近的创伤,恶性肿瘤,脓毒症,和不动。这些病例的平均血细胞比容显着降低(33±7.4%vs38±4.6%,p<0.001)。尽管在病例和对照组之间没有观察到白细胞和血小板计数的差异,但两组之间的白细胞增多与白细胞减少(P=0.003)和血小板增多与血小板减少(P=0.045)分层存在差异。此外,病例中国际标准化比率(INR)较高(1.1±0.2vs1.0±0.1;P=0.001),分别在4.4%和28.9%的病例中观察到高凝状态(INR<0.9)和低凝状态(INR>1.2),而在对照组中没有观察到(P<0.001)。此外,aPTT>40秒分别见于4.4%和4.7%的病例和对照,aPTT<30秒见于22%的病例,但未见于对照(P=0.004)。
    高血压和糖尿病是传统上与DVT无关的危险因素。除了完整的血细胞计数和凝血测试之外,这些还可以用于对我们人群和其他类似社区中的患者进行分层以进行预防。
    UNASSIGNED: Identifying risk factors for venous thromboembolism (VTE) is useful in deciding thromboprophylaxis for VTE. A retrospective study had shown an association between hypertension and diabetes mellitus with VTE in our population. The objective of this study was to confirm these findings and to determine if the complete blood count and coagulation tests can also be useful parameters in stratifying VTE patients for prophylaxis.
    UNASSIGNED: This is a gender and age matched prospective case-control study of 45 Doppler\'s confirmed DVT and 43 apparently healthy controls.
    UNASSIGNED: Identified risk factors included history of hypertension, diabetes mellitus, previous DVT, recent surgery, recent trauma, malignancy, sepsis, and immobility. The cases had a significantly lower mean haematocrit (33±7.4% vs 38±4.6%, p<0.001). Though no differences were observed in leucocyte and platelet counts between cases and controls but stratification as leucocytosis vs leucopaenia (P=0.003) and thrombocytosis vs thrombocytopaenia (P=0.045) differed between both groups. Also, the International normalized ratio (INR) was higher in cases (1.1±0.2 vs 1.0±0.1;P=0.001), hypercoagulable state (INR<0.9) and hypocoagulable state (INR>1.2) were observed in 4.4% and 28.9% of cases respectively but not in controls (P <0.001). Also, aPTT>40 seconds was seen in 4.4% vs 4.7% of cases and controls respectively and aPTT< 30 seconds in 22% of cases but not in controls (P =0.004).
    UNASSIGNED: Hypertension and diabetes mellitus are identified risk factors not traditionally associated with DVT. These in addition to a complete blood count and coagulation tests can be useful in stratifying patients for prophylaxis in our population and other similar communities.
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  • 文章类型: Journal Article
    住院期间和出院后的内科疾病患者的血栓预防仍未得到充分利用。临床决策支持(CDS)如果嵌入工作流程中,可以满足这一需求,在电子健康记录(EHR)之间可互换,并锚定在一个经过验证的模型上。
    本研究的目的是评估基于静脉血栓栓塞加D-二聚体静脉血栓栓塞模型的国际医学预防注册的通用EHR整合CDS工具的临床影响。
    这是一项从2020年12月21日至2022年1月21日对4家三级学术医院进行的整群随机试验。60岁以上有主要医疗疾病的住院患者符合资格。我们在入院和出院时嵌入了CDS。医院被随机分为干预组(CDS;n=2)和常规护理组(n=2)。主要结果是适当的血栓预防率。次要结果包括静脉,动脉,和总血栓栓塞,大出血,以及出院后30天的全因死亡率。
    排除后,对19,823例患者中的10,699例进行了分析。干预组工具采用率为77.8%。干预医院增加了适当的血栓预防,均为住院患者(80.1%vs72.5%,OR:1.52,95%CI:1.39-1.67)和出院时(13.6%vs7.5%,OR:1.93,95%CI:1.60-2.33)。静脉较少(2.7%vs3.3%,OR:0.80,95%CI:0.64-1.00),动脉(0.25%vs0.70%,OR:0.35,95%CI:0.19-0.67),和总血栓栓塞(2.9%vs4.0%,OR:0.71,95%CI:0.58-0.88)在干预医院。大出血很少见,组间没有差异。干预医院的死亡率更高(9.1%vs7.0%,OR:1.32,95%CI:1.15-1.53)。
    在内科住院患者中,嵌入EHR的CDS增加了适当的血栓预防并减少了血栓栓塞,而不增加大出血。干预医院的死亡率较高。
    UNASSIGNED: Thromboprophylaxis for medically ill patients during hospitalization and postdischarge remains underutilized. Clinical decision support (CDS) may address this need if embedded within workflow, interchangeable among electronic health records (EHRs), and anchored on a validated model.
    UNASSIGNED: The purpose of this study was to assess the clinical impact of a universal EHR-integrated CDS tool based on the International Medical Prevention Registry on Venous Thromboembolism plus D-Dimer venous thromboembolism model.
    UNASSIGNED: This was a cluster randomized trial of 4 tertiary academic hospitals from December 21, 2020 to January 21, 2022. Inpatients over age 60 with key medical illnesses were eligible. We embedded CDS at admission and discharge. Hospitals were randomized to intervention (CDS; n = 2) vs usual care (n = 2) groups. The primary outcome was rate of appropriate thromboprophylaxis. Secondary outcomes included venous, arterial, and total thromboembolism, major bleeding, and all-cause mortality through 30 days postdischarge.
    UNASSIGNED: After exclusions, 10,699 of 19,823 patients were analyzed. Intervention group tool adoption was 77.8%. Appropriate thromboprophylaxis was increased at intervention hospitals, both inpatient (80.1% vs 72.5%, OR: 1.52, 95% CI: 1.39-1.67) and at discharge (13.6% vs 7.5%, OR: 1.93, 95% CI: 1.60-2.33). There were fewer venous (2.7% vs 3.3%, OR: 0.80, 95% CI: 0.64-1.00), arterial (0.25% vs 0.70%, OR: 0.35, 95% CI: 0.19-0.67), and total thromboembolisms (2.9% vs 4.0%, OR: 0.71, 95% CI: 0.58-0.88) at intervention hospitals. Major bleeding was rare and did not differ between groups. Mortality was higher at intervention hospitals (9.1% vs 7.0%, OR: 1.32, 95% CI: 1.15-1.53).
    UNASSIGNED: EHR-embedded CDS increased appropriate thromboprophylaxis and reduced thromboembolism without increasing major bleeding in medically ill inpatients. Mortality was higher at intervention hospitals.
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  • 文章类型: Journal Article
    背景:关于静脉血栓栓塞(VTE)的围手术期预防尚无普遍共识,在接受脊柱手术的患者中使用或计时。VTE是当前关注的问题,因为,即使是一个不寻常的事件,它会导致严重的并发症。本研究的目的是提出预防后路脊柱手术中血栓事件的指南。深静脉血栓形成或肺血栓栓塞症。如果获得预防药物的患者数量减少,则可以预期硬膜外血肿的发生率会随之降低。
    方法:研究了在过去五年中接受过脊柱后路关节固定术的235例患者。所有这些都采用了由压力袜组成的机械血栓预防措施。每当观察到血栓形成的危险因素时,也使用抗凝药物。手术后立即恢复早期负重。人口统计,临床,收集手术变量,以及在随访期间出现的并发症,这被安排在一个,两个,四,手术后六个月和十二个月。血栓事件,如果存在,通过超声和CT血管造影等临床和影像学检查诊断。
    结果:在本系列的235名患者中,一百五十三例符合研究纳入标准.总共出现了4起血栓事件,两种形式为深静脉血栓形成,另外两种形式为肺血栓栓塞。这最后两个患有栓塞的患者因此死亡。研究的变量对血栓形成事件的发生无统计学意义。所有4例发生血栓事件的患者均接受抗凝药物治疗,除了机械压缩长袜,因为存在血栓形成的危险因素。
    结论:通过应用上述方案,在接受后路脊柱手术的研究人群中,血栓栓塞事件得到了充分预防.
    BACKGROUND: There is no generalized consensus regarding perioperative prophylaxis of venous thromboembolism (VTE), either on using or timing it in patients undergoing spine surgery. VTE is a current concern because, even though being an uncommon event, it can cause serious complications. The aim of the present study is to propose guidelines for the prevention of thrombotic events in posterior spinal surgery, either as deep vein thrombosis or pulmonary thromboembolism. If the number of patients getting prophylaxis drugs is reduced a subsequent reduction of the incidence of epidural hematoma can be expected.
    METHODS: A number of 235 patients who had undergone posterior spinal arthrodesis in the previous five years were studied. Mechanical thromboprophylaxis measures consisting of compression stockings were applied in all of them. Anticoagulant drugs were also applied whenever risk factors for thrombosis were observed. Early weight-bearing was resumed immediately after surgery. Demographic, clinical, and surgical variables were collected, as well as complications appearing during the follow-up period, that was scheduled at one, two, four, six and twelve months after the surgery. Thrombotic events, if present, were diagnosed by clinical and imaging tests such as ultrasound and CT angiography.
    RESULTS: From the total 235 patients of this series, one hundred and fifty-three cases met the study inclusion criteria. A total of four thrombotic events appeared, one in the form of deep vein thrombosis and other three in the form of pulmonary thromboembolism. These last patients suffering an embolism died because of it. None of the variables studied had statistical significance for the occurrence of a thrombotic event. All four patients who suffered thrombotic events were receiving anticoagulant drugs, in addition to mechanical compression stockings, because of the presence of risk factors for thrombosis.
    CONCLUSIONS: By applying the fore mentioned protocol, adequate prevention of thromboembolic events was achieved in this study population of patients undergoing posterior spinal surgery.
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  • 文章类型: Journal Article
    背景:静脉血栓栓塞(VTE)是一种严重的,频繁,以及住院患者可预防的医疗并发症。尽管已经证明了预防(药理和/或机械)的功效,在国际和国家层面,对预防的依从性很差。
    目的:确定乌拉圭住院患者预防血栓药物的适应证和使用。
    方法:观察性,描述性,描述性横截面,进行了涉及31个全国性医疗机构的多中心研究。与入院相关的基线特征,有血栓预防指征的人口百分比,并评估接受药物血栓预防的患者百分比.使用内科患者的Padua评分确定VTE风险;手术患者的Caprini评分;皇家妇产科学院(RCOG)妊娠产后患者指南。
    结果:纳入1925例患者,代表乌拉圭26%的住院患者。71.9%的患者有发生VTE的风险。在所有有静脉血栓栓塞风险的患者中,58.6%接受药物血栓预防。未接受血栓预防的原因是16.1%的病例中的处方遗漏,15.9%和9.4%的患者因其他原因已经抗凝治疗.总的来说,只有68%的患者受到“保护”以预防VTE。70.1%的高危患者遵循主要血栓预防指南的建议。
    结论:尽管在坚持血栓预防指征方面取得了进展,不坚持仍然是一个问题,影响乌拉圭六分之一有静脉血栓栓塞风险的患者。
    BACKGROUND: Venous thromboembolism (VTE) is a serious, frequent, and preventable medical complication in hospitalized patients. Although the efficacy of prophylaxis (pharmacological and/or mechanical) has been demonstrated, compliance with prophylaxis is poor at international and national levels.
    OBJECTIVE: To determine the indication and use of pharmacological thromboprophylaxis in hospitalized patients in Uruguay.
    METHODS: An observational, descriptive, cross-sectional, multicentre study involving 31 nationwide healthcare facilities was conducted. Baseline characteristics associated with hospital admission, the percentage of the population with an indication for thromboprophylaxis, and the percentage of patients receiving pharmacological thromboprophylaxis were assessed. The VTE risk was determined using the Padua score for medical patients; the Caprini score for surgical patients; the Royal College of Obstetricians and Gynaecologists (RCOG) guidelines for pregnant-postpartum patients.
    RESULTS: 1925 patients were included, representing 26% of hospitalized patients in Uruguay. 71.9% of all patients were at risk of VTE. Of all patients at risk of VTE, 58.6% received pharmacological thromboprophylaxis. The reasons for not receiving thromboprophylaxis were prescribing omissions in 16.1% of cases, contraindication in 15.9% and 9.4% of patients were already anticoagulated for other reasons. Overall, just 68% of patients were \"protected\" against VTE. Recommendations of major thromboprophylaxis guidelines were followed in 70.1% of patients at risk.
    CONCLUSIONS: Despite the progress made in adherence to thromboprophylaxis indications, nonadherence remains a problem, affecting one in six patients at risk of VTE in Uruguay.
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  • 文章类型: Journal Article
    背景:鉴于某些患者的静脉血栓栓塞症(VTE)发病率上升和血栓预防剂量证据不足,精确监测抗Xa(aFXa)水平至关重要。这项研究的目的是调查接受肠胃外抗凝剂的内科住院患者的预防性aFXa水平的成就,并评估各种因素对aFXa水平的影响。
    方法:这是一项单中心观察性队列研究,对伊拉克利翁大学医院内科收治的患者进行,希腊,2023年3月至8月。由于VTE的风险增加,这些个体接受了低分子量肝素血栓预防。有关人口统计的数据,既往病史,并记录躯体测量和实验室检查结果。确定的峰值预防性aFXa水平的范围定义为0.2-0.5IU/mL。
    结果:在这项研究中,我们纳入了150名个体[91名(60.7%)女性],平均年龄为80.0±14.1岁.62例(41.4%)患者表现出非预防性峰值aFXa水平。在所有体重过轻的患者中观察到超治疗水平,在II级和III级的13名肥胖患者中观察到亚治疗水平。多元线性回归分析显示,体重,癌症,Charlson合并症指数(CCI)是影响aFXa水平的独立因素。
    结论:我们的研究揭示了相当一部分老年内科住院患者使用非预防性aFXa水平进行血栓预防,体重过轻和严重肥胖患者的患病率显着。体重,癌症,CCI被确定为影响aFXa水平的独立因素,倡导量身定制的血栓预防策略。需要进一步的研究来验证个性化给药方法并增强临床决策。GeriatrGerontolInt2024;••:••-•。
    BACKGROUND: Given the rising incidence of venous thromboembolism (VTE) and insufficient thromboprophylaxis dosing evidence in certain patients, the precise monitoring of anti-Xa (aFXa) levels is crucial. The aim of this study is to investigate the achievement of prophylactic aFXa levels in medical inpatients who were receiving parenteral anticoagulant and to evaluate the impact of various factors on aFXa levels.
    METHODS: This is a single-center observational cohort study conducted on patients admitted to the Department of Internal Medicine at the University Hospital of Heraklion, Greece, from March to August 2023. These individuals received low-molecular-weight heparins thromboprophylaxis owing to an increased risk of VTE. Data regarding demographics, past medical history, and somatometric and laboratory findings were recorded. The established range for peak prophylactic aFXa levels was defined as 0.2-0.5 IU/mL.
    RESULTS: In this study, we enrolled 150 individuals [91 (60.7%) women] with a mean age of 80.0 ± 14.1 years. Sixty-two (41.4%) patients exhibited non-prophylactic peak aFXa levels. Supratherapeutic levels were observed in all underweight patients and subtherapeutic levels in 12 of 13 obese patients in class II and III. A multivariate linear regression analysis revealed that body weight, cancer, and the Charlson Comorbidity Index (CCI) were independent factors influencing aFXa levels.
    CONCLUSIONS: Our study reveals a substantial portion of medical elderly inpatients on thromboprophylaxis with non-prophylactic aFXa levels, with a notable prevalence among underweight and severely obese patients. Body weight, cancer, and CCI were identified as independent factors influencing aFXa levels, advocating for tailored thromboprophylaxis strategies. Further research is warranted to validate personalized dosing approaches and to enhance clinical decision-making. Geriatr Gerontol Int 2024; 24: 587-594.
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  • 文章类型: Journal Article
    目的:静脉血栓栓塞症(VTE)是肺癌开胸手术患者的严重并发症。然而,因为证据不足,目前尚无明确的指南,VTE的预防措施差异很大.这项全国范围的队列研究是一项比较研究,调查了外科部门的VTE风险,与常规使用低分子量肝素(LMWH)进行院内血栓预防相比,没有。
    方法:我们确定了2010-2021年在丹麦接受手术的所有非小细胞肺癌(NSCLC)患者。胸外科手术仅在四所大学医院进行。自2000年以来,三家医院实施了院内血栓预防作为标准护理,而第四家医院于2016年9月采用了这种做法。随访6个月,根据医院和研究期间评估VTE事件,使用逆概率的治疗加权方法。
    结果:我们确定了9,615例患者。在六个月的随访中,共观察到190例VTE事件,导致每100人年4.5个事件的加权率和2.2%的绝对风险.根据医院场所或医院内血栓预防的使用,没有明确的趋势,不使用血栓预防的医院风险为2.2%,而使用血栓预防的医院风险为1.7%-3.1%。
    结论:使用院内血栓预防并不影响NSCLC手术后VTE的风险,提示仅依靠院内血栓预防可能不足以减轻这些患者的VTE风险.进一步的研究是必要的,以调查延长血栓预防在降低选定的NSCLC手术患者的VTE风险的潜在益处。
    OBJECTIVE: Venous thromboembolic event (VTE) is a severe complication in patients with lung cancer undergoing thoracic surgery. Nevertheless, because of insufficient evidence, there are no clear guidelines, and VTE prophylaxis practices vary widely. This nationwide cohort study was a comparative study investigating VTE risk in surgical departments that routinely administered in-hospital thromboprophylaxis with low-molecular-weight heparin compared to those that did not.
    METHODS: We identified all patients with non-small-cell lung cancer (NSCLC) who underwent surgery in Denmark during 2010-2021. Thoracic surgery was exclusively performed in the 4 university hospitals. Three hospitals implemented in-hospital thromboprophylaxis as standard care since 2000, while the fourth adopted this practice in September 2016. VTE events were assessed at 6-month follow-up according to hospital and study period, using an inverse probability of treatment weighting approach.
    RESULTS: We identified 9615 patients. During 6-month follow-up, a total of 190 VTE events were observed, resulting in a weighted rate of 4.5 events per 100 person-years and an absolute risk of 2.2%. There was no clear trend according to hospital site or use of in-hospital thromboprophylaxis with a 2.2% risk in the hospital not using thromboprophylaxis compared to 1.7-3.1% in those that did.
    CONCLUSIONS: Use of in-hospital thromboprophylaxis did not affect the risk of VTE after surgery for NSCLC, suggesting that relying solely on in-hospital thromboprophylaxis may be insufficient to mitigate VTE risk in these patients. Further research is warranted to investigate the potential benefits of extended thromboprophylaxis in reducing VTE risk in selected NSCLC surgical patients.
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  • 文章类型: Journal Article
    背景:本研究的目的是记录和评估中剂量替扎肝素在高血栓风险肺癌患者中预防血栓的有效性和安全性。
    方法:这是非干预性的,单臂,肺癌患者接受Tinzaparin10.000Anti-XaIU在0.5mL的血栓预防的前瞻性队列研究,OD,用于当前的临床实践。住院患者签署知情同意书。测试抗Xa水平。
    结果:总计,140名患者被纳入研究,其中男性占81.4%。肿瘤的组织学主要是腺癌。肺癌患者的高血栓形成风险基于肿瘤,病人,治疗,并纳入实验室相关因素.只有一名患者出现血栓形成事件(0.7%),10例患者发生出血事件(7.1%),只包括一个重大事件。在10天和3个月测量的抗Xa水平在发生出血事件的患者和未发生出血事件的患者之间没有显着差异(分别为p=0.26和p=0.32)。
    结论:在高血栓形成风险的肺癌患者中使用中等剂量的Tinzaparin预防血栓是预防VTE的安全有效选择。
    BACKGROUND: The aim of this study was to record and assess the efficacy and safety ofthromboprophylaxis with an intermediate dose of Tinzaparin in lung cancer patients with high thrombotic risk.
    METHODS: This was a non-interventional, single-arm, prospective cohort study of lung cancer patients who received thromboprophylaxis with Tinzaparin 10.000 Anti-Xa IU in 0.5 mL, OD, used in current clinical practice. Enrolled ambulatory patients signed informed consent. Anti-Xa levels were tested.
    RESULTS: In total, 140 patients were included in the study, of which 81.4% were males. The histology of the tumor was mainly adenocarcinoma. Lung cancer patients with high thrombotic risk based on tumor, patient, treatment, and laboratory-related factors were enrolled. Only one patient experienced a thrombotic event (0.7%), and 10 patients had bleeding events (7.1%), including only one major event. Anti-Xa levels measured at 10 days and 3 months did not differ significantly between patients who developed hemorrhagic events and those who did not (p = 0.26 and p = 0.32, respectively).
    CONCLUSIONS: Thromboprophylaxis with an intermediate Tinzaparin dose in high thrombotic-risk lung cancer patients is a safe and effective choice for the prevention of VTE.
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  • 文章类型: Journal Article
    多发性骨髓瘤(MM)在治疗开始后6个月内显着增加了静脉血栓栓塞(VTE)的风险。IMPEDEVTE评分是一种VTE风险预测模型,最近被纳入国家综合癌症网络(NCCN)指南。但它缺乏亚洲人的验证,包括中国MM患者。我们对2013年4月至2022年10月在北京积水潭医院开始治疗的405例中国新诊断MM进行了回顾性图表回顾。VTE的6个月累积发生率为3.8%(95%CI:1.6-7.6),8.6%(95%CI:5.3-21.9)和40.5%(95%CI:24.9-55.7),中危和高危人群(P<0.001),分别。在治疗开始后6个月内预测VTE的IMPEDEVTE评分的C统计量为0.74(95%CI:0.65-0.83)。值得注意的是,在这项单中心队列研究中,我们认为,在新诊断的MM患者中,抗凝LMWH可能比抗血小板阿司匹林更有效地预防VTE.我们的研究结果表明,IMPEDEVTE评分是中国新诊断MM患者的有效的基于证据的风险分层工具。
    Multiple myeloma (MM) significantly increases the risk of venous thromboembolism (VTE) within 6 months of treatment initiation. The IMPEDE VTE score is a VTE risk prediction model which is recently incorporated into the National Comprehensive Cancer Network (NCCN) guidelines, but it lacks validation among Asians, including Chinese MM patients. We performed a retrospective chart review of 405 Chinese with newly diagnosed MM who started therapy at Beijing Jishuitan Hospital between April 2013 to October 2022. The 6-month cumulative incidence of VTE was 3.8 % (95 % CI:1.6-7.6), 8.6 % (95 % CI: 5.3-21.9) and 40.5 % (95 % CI: 24.9-55.7) in the low-, intermediate- and high-risk groups (P < 0.001), respectively. The C-statistic of the IMPEDE VTE scores for predicting VTE within 6 months of treatment initiation was 0.74 (95 % CI: 0.65-0.83). Of note, in this single-center cohort study, we propose that the anticoagulant LMWH may be more effective than the antiplatelet aspirin in potentially preventing VTE in newly diagnosed MM patients. Our findings suggest that the IMPEDE VTE score is a valid evidence-based risk stratification tool in Chinese patients with newly diagnosed MM.
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  • 文章类型: Journal Article
    背景:住院患者的静脉血栓栓塞症(VTE)是发病率和死亡率的重要原因。指南建议应将VTE和出血风险评估模型(RAM)整合到血栓预防的临床决策过程中。然而,在评估VTE和出血发生时,使用RAM与临床判断进行比较的证据不足.方法减少住院内科患者(RICO)的重要临床结局是一个多中心的,集群随机化,对照临床试验(ClinicalTrials.gov标识符:NCT04267718)。在内科病房住院的重症患者被随机分配使用RAM,即帕多瓦预测评分和静脉血栓栓塞出血国际医学预防注册评分,或进行临床判断。主要研究结果是90天随访时症状性客观证实的VTE和大出血的复合结果。次要终点包括评估出院时的临床结果和评估研究期间的VTE预防处方。为了证明实验组的主要结局减少了50%,并假设对照组在90天的主要结局发生率为3.5%;该研究将包括32个中心的2,844名患者。讨论RICO试验是一项临床管理的随机研究,旨在评估RAM在住院内科患者中的作用,目的是减少VTE和出血的发生。该研究有可能改善临床实践,因为VTE仍然是这种情况下发病率和死亡率的重要原因。
    Background  Venous thromboembolism (VTE) in hospitalized medically ill patients is a significant cause of morbidity and mortality. Guidelines suggest that VTE and bleeding risk assessment models (RAMs) should be integrated into the clinical decision-making process on thromboprophylaxis. However, poor evidence is available comparing the use of a RAM versus clinical judgement in evaluating VTE and bleeding occurrence. Methods  Reducing Important Clinical Outcomes in hospitalized medical ill patients (RICO) is a multicenter, cluster-randomized, controlled clinical trial (ClinicalTrials.gov Identifier: NCT04267718). Acutely ill patients hospitalized in Internal Medicine wards are randomized to the use of RAMs-namely the Padua Prediction Score and the International Medical Prevention Registry on Venous Thromboembolism Bleeding Score-or to clinical judgement. The primary study outcome is a composite of symptomatic objectively confirmed VTE and major bleeding at 90-day follow-up. Secondary endpoints include the evaluation of clinical outcomes at hospital discharge and the assessment of VTE prophylaxis prescription during the study period. In order to demonstrate a 50% reduction in the primary outcome in the experimental group and assuming an incidence of the primary outcome of 3.5% in the control group at 90-day; 2,844 patients across 32 centers will be included in the study. Discussion  The RICO trial is a randomized study of clinical management assessing the role of RAMs in hospitalized medical ill patients with the aim of reducing VTE and bleeding occurrence. The study has the potential to improve clinical practice since VTE still represents an important cause of morbidity and mortality in this setting.
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  • 文章类型: Journal Article
    临床风险评估评分,例如IMPEDEVTE,可以识别多发性骨髓瘤(MM)患者的静脉血栓栓塞症(VTE)高风险。这些分数的细化,通过包括一种或多种生物标志物,可以改善风险评估。
    我们试图确定MM中可溶性P-选择素(sP-选择素)和D-二聚体与VTE之间的关联。
    我们确定了545例新诊断的MM患者。使用嵌套的大小写控件设计,我们确定了38例MM治疗6个月内的VTE和137例随机选择的对照.使用逻辑回归,我们检测了D-二聚体和sP-选择素与VTE的相关性.我们还分析了调整后的相关性。
    IMPEDEVTE评分每增加1分,VTE几率增加27%(比值比1.27;95%CI1.08-1.51;c统计0.61;95%CI0.51-0.71)。sP-选择素与VTE之间无相关性。D-二聚体自然对数的每一次增加与VTE几率增加44%相关,所以我们给D-二聚体值分配了点(范围从-2到+2),并将它们合并到IMPEDEVTE中,形成改良的VTE。每增加1个百分点,VTE的几率增加30%(OR1.30;95%CI1.12-1.52;c统计0.65;95%CI0.55-0.75)。
    在新诊断的MM开始化疗的患者中,D-二聚体与随后6个月内发生VTE的几率增加相关。在IMPEDEVTE-IMPEDEDVTE-中添加D-二聚体可以改善MM患者对VTE的预测。
    UNASSIGNED: Clinical risk assessment scores, such as IMPEDE VTE, can identify patients with multiple myeloma (MM) at high-risk of venous thromboembolism (VTE). Refinement of these scores, by including 1 or more biomarkers, could improve risk assessment.
    UNASSIGNED: We sought to determine the association between soluble P-selectin (sP-selectin) and D-dimer with VTE in MM.
    UNASSIGNED: We identified 545 patients with newly diagnosed MM. Using a nested case-control design, we identified 38 cases of VTE within 6-months of MM treatment and 137 randomly selected controls. Using logistic regression, we examined the association between D-dimer and sP-selectin with VTE. We also analyzed the association after adjusting for IMPEDE VTE.
    UNASSIGNED: Each 1-point increase in IMPEDE VTE score was associated with a 27% increase in odds of VTE (odds ratio 1.27; 95% CI 1.08-1.51; c-statistic 0.61; 95% CI 0.51-0.71). There was no association between sP-selectin and VTE. Each one increase in natural log of D-dimer was associated with a 44% increase in odds of VTE, so we assigned points (ranging from -2 to +2) to D-dimer values and incorporated them into IMPEDE VTE, forming IMPEDED VTE. There was a 30% increase in odds of VTE per each 1-point increase in IMPEDED VTE (OR 1.30; 95% CI 1.12-1.52; c-statistic 0.65; 95% CI 0.55-0.75).
    UNASSIGNED: Among patients with newly diagnosed MM starting chemotherapy, D-dimer was associated with increased odds of developing VTE within the subsequent 6-months. The addition of D-dimer to IMPEDE VTE-IMPEDED VTE-could improve prediction of VTE among patients with MM.
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