A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery or Procedure (ANNEXA-RS)

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

开始日期2024-08-02

申办/合作机构

AstraZeneca PLC

NCT06255496 / Enrolling by invitationN/A

Evaluation of the Clinical Performance of the Quantra® System With the QStat® Cartridge in Obstetric Patients

This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

开始日期2024-05-09

申办/合作机构

HemoSonics LLC

NCT06322186 / Not yet recruitingN/AIIT

Study to Actively Warm Trauma Patients-2 (STAYWARM-2): A Pilot Feasibility Trial of Chemical Versus Passive Warming Blankets in Massively Bleeding Patients

Massively bleeding trauma patients have higher odds of mortality, increased hospital length of stay, and increased need for transfusion if they become hypothermic. Hypothermia is independently associated with mortality in traumatically injured patients due to its negative physiologic effects on hemostasis, cardiorespiratory and renal function.
Current warming strategies increase the logistical difficulty of transferring patients (which is frequent during the initial hours of trauma care) or must be changed at frequent intervals. Prehospital, military, and intraoperative studies have suggested chemical warming blankets as a pragmatic strategy to manage hypothermia. A recent pilot study (manuscript under review) at our institution demonstrated the feasibility of using the Ready-Heat® (TechTrade LLC, Orlando, FL, USA) chemical heating blanket in the initial phases of hospital care in bleeding trauma patients requiring a mass hemorrhage protocol (MHP). These self-warming blankets provide warmth over 8 hours at up to 40 degrees Celsius, carrying the advantage of portability with no continuous electric power requirement. Furthermore, the Ready-Heat blanket may be more effective than current strategies for rewarming patients at high risk of developing hypothermia. STAYWARM-2 will be the first randomized controlled trial performed in-hospital to evaluate a self-warming blanket to address hypothermia in massively bleeding trauma patients within the initial hours of hospital arrival.
This study will help to determine the efficacy and feasibility of using chemical heating blankets for hypothermia in the early hours of hospital care. This has potential to reduce the overall workload of direct care clinicians, freeing them for other patient care duties. Additionally, the intervention may achieve enhanced thermoregulation compared to current strategies, improving patient care and comfort, and avoiding the clinical complications related to hypothermia. Findings from this preliminary study may provide data for a future grant to launch a larger randomized controlled trial in the prehospital/in-hospital trauma setting to optimize the care of patients at risk of developing hypothermia.

开始日期2024-03-01

申办/合作机构

Sunnybrook Health Sciences Centre

100 项与大出血相关的临床结果

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100 项与大出血相关的转化医学

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0 项与大出血相关的专利（医药）

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11,604

项与大出血相关的文献（医药）

2025-04-01·DEN Open

Appendicitis after endoscopic band ligation for massive ileocecal hemorrhage

作者: Sato, Hiroto ; Kanno, Takeshi ; Kaizuka, Akira ; Toda, Makoto ; Ohtaki, Yu ; Yamamoto, Yu ; Fujishima, Shoichiro ; Shirahata, Nakao ; Ae, Ryusuke

AbstractA 68‐year‐old man was admitted with hematochezia. Emergency computed tomography showed multiple diverticula throughout the colon. Initial colonoscopy on day 2 showed no active bleeding, but massive hematochezia on day 3 led to the performance of an emergency endoscopy. Substantial bleeding in the ileocecal area obscured the visual field, making it challenging to view the area around the bleeding site. Two endoscopic band ligations (EBLs) were applied at the suspected bleeding sites. Hemostasis was achieved without active bleeding after EBL. However, the patient developed lower right abdominal pain and fever (39.4°C) on day 6. Urgent computed tomography revealed appendiceal inflammation, necessitating emergency open ileocecal resection for acute appendicitis. Pathological examination confirmed acute phlegmonous appendicitis, with EBLs noted at the appendiceal orifice and on the anal side. This case illustrates the efficacy of EBL in managing colonic diverticular bleeding. However, it also highlights the risk of appendicitis due to EBL in cases of ileocecal hemorrhage exacerbated by poor visibility due to substantial bleeding. Endoscopists need to consider this rare but important complication when performing EBL in similar situations.

2024-12-31·Scandinavian Cardiovascular Journal

Bleeding is associated with severely impaired outcomes in surgery for acute type a aortic dissection

Article

作者: Olsson, Christian ; Jeppsson, Anders ; Bratt, Sorosh ; Ede, Jacob ; Gunn, Jarmo ; Gudbjartsson, Tomas ; Zindovic, Igor ; Mennander, Ari ; Dalén, Magnus ; Tang, Mariann ; Geirsson, Arnar ; Wickbom, Anders ; Hansson, Emma C. ; Uimonen, Mikko

Background. Surgery for acute type A aortic dissection confers a risk for significant bleeding. We analyzed the impact of massive bleeding on complications after surgery for acute type A aortic dissection. Methods. Patients undergoing surgery for acute type A aortic dissection from the retrospective multicenter Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD) database 2005-2014 were eligible. Massive bleeding was defined according to the Universal Definition of Perioperative Bleeding. The primary outcome measure was early mortality and secondary outcome measures were perioperative stroke, mechanical ventilation more than 48 h, new-onset dialysis, and intensive care unit stay. Propensity score matching was performed to adjust for differences in covariates. Results. Nine hundred ninety-seven patients were included, of whom 403 (40.4%) had massive bleeding. In the propensity score-matched cohort (344 pairs), patients with massive bleeding had higher 30-day mortality (17.2 versus 7.6%, p < .001), mechanical ventilation more than 48 h (52.8 versus 22.6%, p < .001), perioperative stroke (24.3 versus 14.8%, p = .002), new-onset dialysis (22.5 versus 4.9%, p < .001), and longer intensive care unit stay (6 versus 3 days, p < .001), compared with patients without massive bleeding. Risk factors for massive bleeding were previous cardiac surgery, preoperative clopidogrel or ticagrelor therapy, DeBakey type I dissection, and localized or generalized malperfusion. Conclusions. Massive bleeding in surgery for acute type A aortic dissection is associated with a markedly increased risk for severe complications as well as early death. Further improvement of surgical technique and pharmacological optimization of coagulation is paramount to possibly improve outcomes in acute type A aortic dissection repair.

2024-12-31·NMC Case Report Journal

A Case of Bilateral Lambdoid and Sagittal Synostosis Diagnosed with Skull Fracture after Vacuum-assisted Delivery: A Case Report and Literature Review

Article

作者: Nakamura, Natsuki ; Maeno, Kazushige ; Ueda, Koichi ; Harada, Atsuko ; Kyutoku, Shigeo

Craniosynostosis (CS) can develop in the fetal period, but it is difficult to diagnose prenatally. In this case, a 3-month-old female baby developed extensive subgaleal hematoma and severe anemia after vacuum-assisted delivery. Her computed tomography showed bilateral lambdoid and sagittal synostosis (BLSS) with a depressed fracture of the right parietal bone. She was referred to our hospital for treatment of the CS. At 4 months of age, she underwent bilateral lambda and sagittal suturectomy and foramen magnum decompression. CS may result in trauma at delivery, because CS disturbs fetal head molding during delivery and disrupts passage through the birth canal. In particular, the risk of severe peripartum trauma is thought to increase in cases of CS with multiple suture fusions, such as those observed in BLSS, due to the strong inhibition of this process of passage through the birth canal. Therefore, if the delivery is abnormally prolonged or if the infant has a massive subgaleal hematoma, it is important to perform evaluations for CS after birth.

项与大出血相关的新闻（医药）

2024-10-21

·PRNewswire

nCartes Rolls Out REDCap Integration in Collaboration with UC Davis Medical Center

FREMONT, Calif., Oct. 21, 2024 /PRNewswire/ -- nCartes, Inc, a leader in EHR-to-EDC clinical trial data fulfillment, has gone live with its REDCap EDC integration capability in collaboration with UC Davis Medical Center. The nCartes vision is to transform clinical research by enabling research sites and sponsors to harness EMR data efficiently and accurately in study fulfillment. nCartes adds the REDCap integration to its existing library of successfully installed EHR-to-EDC systems. REDCap is among the most widely used EDC systems worldwide with more than 7,000 registered institutional users in 159 countries and 2 million projects. By adding this integration, nCartes enables our customers to benefit from data quality improvement and time savings benefits on their REDCap-based studies. "Our goal is to support customer needs across each of the industry-sponsored trials, government-sponsored trial networks, and investigator-initiated trials," says nCartes CEO John McIlwain. "Adding the REDCap integration opens nCartes' benefits to a large group of medical researchers who use REDCap to support their study data needs." The nCartes team worked closely with UC Davis Medical Center (UCDMC) under the leadership of Rachael Callcut, MD, MSPH, FACS in the roll-out of its REDCap feature. Dr. Callcut is the UCDMC Division Chief, Trauma, Acute Care Surgery and Surgical Critical Care, Chief Research Information Officer, Vice Chair Clinical Data Science, and Associate Dean of Data Science & Innovation. The initial nCartes-REDCap UCDMC study, called ACIT, is a trauma study designed to address gaps in clinical knowledge in massive hemorrhage treatment. In the US, trauma is the leading cause of death for persons aged 1-45 years old. Hemorrhage is the largest contributing factor in preventable death. For the ACIT study, nCartes supported collection of 461 data points per study subject by leveraging data from the UCDMC EMR. As part of the data transfer, nCartes: Eliminated duplicate data entry Assembled similarly named labs for easy and accurate data capture Automated unit conversions Standardized decimal places Eliminated similar-named lab results not applicable to the study Automated field value calculations Converted numeric source data to binary values where necessary to meet study objectives. The project surpassed expectations in the level of automation and accuracy nCartes achieved. "The integration of nCartes with REDCap marks a significant advancement in streamlining clinical research efficiency," says Dr. Callcut. "By working together with the nCartes team, we were able to tailor the product to accurately capture research information through automated extraction of electronic medical record data. This allowed our research team to focus their time on important patient-facing research activities, rather than being bogged down on repetitive tasks with a high risk of error in manual data extraction." nCartes and UCDMC are pursuing additional uses of the nCartes-REDCap capability including an expansion of the ACIT trial expected to accrue as many as 500 additional patients in a new study focused on digital biomarkers for trauma patients. About nCartes: nCartes, Inc. () is a transformational cloud software platform provider. The nCartes platform enables clinical research sponsors and research sites to harness electronic health systems (EHRs) to automate data capture for clinical trials, patient registries, cell manufacturing and more. CONTACT: [email protected] SOURCE nCoup, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究

2024-10-18

·同写意

澳大利亚监管机构拒批卫材/渤健AD新药

此次医博会由同写意策划，以“发展新质生产力，共享健康新未来”为主题，用全新的视角瞄准国内外医药及大健康产业发展前沿。诚邀海内外医药及大健康各界嘉宾齐聚中国医药城，共赴时代之约。展位/报告火热征集中！澳大利亚治疗品管理局（TGA）表示，不会批准卫材和渤健的阿尔茨海默病治疗药物Leqembi（lecanemab），因为其疗效并未大于风险。该监管机构对此的解释是，尽管在关键的Clarity AD试验中，接受Leqembi治疗的患者与接受安慰剂治疗的患者相比，疾病进展减少，“但这种差异不足以提供有意义的临床获益或大于相关的安全风险”。 TGA引用了使用抗淀粉样蛋白药物的患者出现脑肿胀或出血的案例，即淀粉样蛋白相关性影像异常（ARIA），称其立场是根据下设的药物咨询委员会（ACM）的建议。患者权益组织澳大利亚痴呆症协会评论道，他们对TGA的决定感到失望，认为这将剥夺澳大利亚人痴呆患者获得新疗法潜在益处的选择。卫材澳大利亚公司表示会在90天内提交申请，请求TGA重新考虑这个决定，后者必须在60天内做出回应。无独有偶，今年7月，欧盟监管机构也对Leqembi给出了类似的态度，EMA的药品委员会（CHMP）对卫材和渤健的阿尔茨海默症药物Leqembi的批准给出负面意见。当时，CHMP表示，虽然在主要研究中，大多数ARIA病例并不严重，也没有症状，但有些患者出现了严重的症状，包括脑部大出血，需要住院治疗。此外，该机构还担心携带APOE4蛋白基因的人患ARIA的风险更高。随后，卫材和渤健报告了Clarity AD的最新结果。数据显示，与基线相比，接受Leqembi治疗的最早期阿尔茨海默病患者亚群中，51%在三年内表现出持续的认知和功能改善，这些患者在基线时大脑没有检测到Tau蛋白或Tau蛋白水平很低。持续三年使用lecanemab治疗未观察到新的安全问题。大多数淀粉样蛋白相关成像异常（ARIA）发生在治疗的首六个月。六个月后，ARIA的发生率较低，与安慰剂组相似。报告称治疗的益处会随着时间的推移而增加。 Leqembi已经在美国、日本、中国、韩国、香港、以色列、阿联酋和英国获得批准，且已登陆美国、日本和中国市场。今年第二季度，Leqembi销售额达到4000万美元，高于今年前三个月的1700万美元和2023年全年的1000万美元。虽然Leqembi的销售有所放缓，但有回升的迹象。参考文章： 1、Australia joins EU in turning down Alzheimer's drug Leqembi；pharmaphorum 2、卫材/渤健阿尔茨海默病疗法3年长期数据公布！；药明康德同写意媒体矩阵，欢迎关注↓↓↓

2024-10-18

·BioSpace

Cerus Corporation Announces Workshop and Abstracts at the 2024 AABB Annual Meeting

Presentations Highlight the Unique Benefits of Real-world Utilization of INTERCEPT-treated Blood Products, Including INTERCEPT Fibrinogen Complex, and Recent Findings from the Phase 3 ReCePI Clinical Trial CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) today announced a selection of abstracts to be presented at the 2024 Association for the Advancement of Blood & Biotherapies (AABB) Annual Meeting, taking place in Houston, Texas from October 19 through October 22. This year’s AABB Annual Meeting attracts individuals and institutions from around the globe involved in the fields of transfusion medicine and biotherapies. The following is a select list of Cerus-related presentations and abstracts. All presentation times are listed in Central Daylight Time (CDT). Oral Presentations Sunday, October 20, 2024 – 9:30 a.m.– Acute Kidney Injury to Evaluate Amustaline/Glutathione Pathogen Reduced Red Cells in Cardiac Surgery: Outcomes of the ReCePI Phase III Clinical Trial (Speaker: E. Snyder) Monday, October 21 – 9:45 a.m. – Utilizing Sankey Diagrams to Quantify Laboratory Efficiency of INTERCEPT Fibrinogen Complex vs Traditional Cryoprecipitate (Speaker: D. Chen) Monday, October 21, 2024 – 2:00 p.m. – Phase IV Trial of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOPCLOT) in Cardiac Surgery (Speaker: M. Cushing) Monday, October 21, 2024 – 2:00 p.m. – HLA Alloimmunization in ReCePI, a Phase III Study of Amustaline/Glutathione Pathogen Reduced RBCs (Speaker: P. Norris) Monday, October 21, 2024 – 2:00 p.m. – Treatment-Emergent Antibodies to Amustaline/Glutathione Pathogen-Reduced Red Blood Cells in the ReCePI Phase III Clinical Trial (Speaker: R. Benjamin) Poster Presentations Held Sunday, October 20 and Monday, October 21, 2024 Evaluation of Pathogen Reduction Efficacy in Platelet Concentrates Until End of Shelf-Life with Two Different Automated Bacterial Detection Systems Development of a Next Generation Illuminator for Photochemical Inactivation of a Broad Spectrum of Pathogens in Platelet Concentrates Accelerating Treatment Delivery and Reducing Waste with Implementation of Pathogen Reduced Cryoprecipitated Fibrinogen Complex Wastage and Cost Analysis for INTERCEPT Fibrinogen Complex An Analysis of Anesthesiologist and Transfusion Service Staff Preferences Between Pathogen Reduced Cryoprecipitated Fibrinogen Complex and Conventional Cryoprecipitated AHF Analysis of Wastage, Savings, and Maternal and Pediatric Outcomes for Pooled Pathogen Reduced Cryoprecipitate versus Conventional Cryoprecipitate Pathogen Reduced Cryoprecipitate Implementation and Assessment of Its Impact in a Large Academic Medical Center Implementation of INTERCEPT Fibrinogen Complex (IFC) for Postpartum Hemorrhage Evaluation of INTERCEPT RBC Pathogen Reduction in Combination with Irradiation Industry Workshop Monday, October 21, 2024 – 7:00 a.m.– Industry Workshop Presented by Cerus: Pathogen Reduced Blood Components – Current Experiences and Future Developments with the INTERCEPT® Blood System (Speakers: J. Squires, C. Ingold, E. Snyder) The full program of Cerus-related abstracts can be found at the following link: Cerus representatives will be in the exhibition area at booth #431. ABOUT CERUS Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both C.E mark and FDA approval for these two blood components. In the U.S, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is in late-stage clinical development. For more information about Cerus, visit and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Contacts Jessica Hanover Cerus Corporation 925-288-6137

临床3期