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      Occurrence rates and risk factors of in-hospital venous thromboembolism, major bleeding, and death in patients receiving fondaparinux after orthopedic surgery or trauma surgery

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          Abstract

          Aim

          Fondaparinux is a synthetic anticoagulant that inhibits thrombosis by suppressing factor Xa. The efficacy of fondaparinux for orthopedic surgeries has been revealed by several foreign studies; however, relevant evidence in Chinese patients is lacking. This study intended to investigate the occurrence rate and risk factors of in-hospital venous thromboembolism (VTE), major bleeding, and death in patients receiving fondaparinux after orthopedic surgery or trauma surgery.

          Methods

          Totally, 1258 patients who received fondaparinux after orthopedic surgery or trauma surgery were retrospectively enrolled. Meanwhile, in-hospital VTE, major bleeding, and death were obtained for assessment. Besides, adverse events were recorded.

          Results

          The occurrence rates of in-hospital VTE, major bleeding, and death were 2.5%, 21.8%, and 0.0%, respectively. The multivariate logistic regression analysis revealed that only age (> 60 years vs. ≤ 60 years) (odd ratios (OR) = 3.380, P = 0.013) was independently correlated with increased risk of in-hospital VTE. Additionally, osteoarthritis diagnosis (OR = 3.826, P < 0.001), femoral head necrosis diagnosis (OR = 1.809, P = 0.034), hip replacement (vs. internal fracture fixation) (OR = 2.199, P = 0.007), knee replacement (vs. internal fracture fixation) (OR = 2.781, P = 0.002), and serum creatinine (abnormal vs. normal) (OR = 1.677, P = 0.012) were independently linked to a higher risk of in-hospital major bleeding. Moreover, the common adverse events included pain (56.6%), wound bleeding (23.0%), increased drainage (5.2%), etc.

          Conclusion

          Fondaparinux realizes low occurrence rates of in-hospital VTE and major bleeding with tolerable adverse events in patients receiving orthopedic surgery or trauma surgery.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s11845-023-03289-7.

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          Most cited references32

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          Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.

          VTE is a serious, but decreasing complication following major orthopedic surgery. This guideline focuses on optimal prophylaxis to reduce postoperative pulmonary embolism and DVT. The methods of this guideline follow those described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines in this supplement. In patients undergoing major orthopedic surgery, we recommend the use of one of the following rather than no antithrombotic prophylaxis: low-molecular-weight heparin; fondaparinux; dabigatran, apixaban, rivaroxaban (total hip arthroplasty or total knee arthroplasty but not hip fracture surgery); low-dose unfractionated heparin; adjusted-dose vitamin K antagonist; aspirin (all Grade 1B); or an intermittent pneumatic compression device (IPCD) (Grade 1C) for a minimum of 10 to 14 days. We suggest the use of low-molecular-weight heparin in preference to the other agents we have recommended as alternatives (Grade 2C/2B), and in patients receiving pharmacologic prophylaxis, we suggest adding an IPCD during the hospital stay (Grade 2C). We suggest extending thromboprophylaxis for up to 35 days (Grade 2B). In patients at increased bleeding risk, we suggest an IPCD or no prophylaxis (Grade 2C). In patients who decline injections, we recommend using apixaban or dabigatran (all Grade 1B). We suggest against using inferior vena cava filter placement for primary prevention in patients with contraindications to both pharmacologic and mechanical thromboprophylaxis (Grade 2C). We recommend against Doppler (or duplex) ultrasonography screening before hospital discharge (Grade 1B). For patients with isolated lower-extremity injuries requiring leg immobilization, we suggest no thromboprophylaxis (Grade 2B). For patients undergoing knee arthroscopy without a history of VTE, we suggest no thromboprophylaxis (Grade 2B). Optimal strategies for thromboprophylaxis after major orthopedic surgery include pharmacologic and mechanical approaches.
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            2019 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer

            Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer. These patients are at a high risk of VTE recurrence and bleeding during anticoagulant therapy. The International Initiative on Thrombosis and Cancer is an independent academic working group aimed at establishing a global consensus for the treatment and prophylaxis of VTE in patients with cancer. The International Initiative on Thrombosis and Cancer last updated its evidence-based clinical practice guidelines in 2016 with a free, web-based mobile phone application, which was subsequently endorsed by the International Society on Thrombosis and Haemostasis. The 2019 International Initiative on Thrombosis and Cancer clinical practice guidelines, which are based on a systematic review of the literature published up to December, 2018, are presented along with a Grading of Recommendations Assessment Development and Evaluation scale methods, with the support of the French National Cancer Institute. These guidelines were reviewed by an expanded international advisory committee and endorsed by the International Society on Thrombosis and Haemostasis. Results from head-to-head clinical trials that compared direct oral anticoagulant with low-molecular-weight heparin are also summarised, along with new evidence for the treatment and prophylaxis of VTE in patients with cancer.
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              Venous thromboembolism

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                Author and article information

                Contributors
                lapo5160007@163.com
                Journal
                Ir J Med Sci
                Ir J Med Sci
                Irish Journal of Medical Science
                Springer International Publishing (Cham )
                0021-1265
                1863-4362
                14 February 2023
                14 February 2023
                2023
                : 192
                : 6
                : 2973-2979
                Affiliations
                [1 ]Department of Orthopedics, Anhui Spinal Deformities Clinical Medical Research Center, Fuyang People’s Hospital, ( https://ror.org/00p1jee13) No. 501 Sanqing Road, Fuyang, Anhui 236000 China
                [2 ]Department of Orthopedics, The First Affiliated Hospital of Xinxiang Medical University, ( https://ror.org/0278r4c85) Xinxiang, 453000 China
                [3 ]Department of Orthopedics, Xinyi People’s Hospital, ( https://ror.org/011r8ce56) Xuzhou, 221400 China
                [4 ]Department of Orthopedics, Affiliated Hospital of Jiangsu University, ( https://ror.org/028pgd321) Zhenjiang, 212001 China
                [5 ]Department of Orthopedics, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, ( https://ror.org/02dx2xm20) Xiangyang, 441021 China
                [6 ]Department of Traumatology, The Affiliated Taian City Central Hospital of Qingdao University, ( https://ror.org/04vsn7g65) Taian, 271000 China
                Author information
                http://orcid.org/0000-0001-6422-0158
                Article
                3289
                10.1007/s11845-023-03289-7
                10692026
                36787027
                af9b3d6b-dfd1-4298-9deb-5e91ca90e42c
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 20 December 2022
                : 18 January 2023
                Funding
                Funded by: FundRef NO.2020810029; NO.202081029, Fu Yang Science and Technology Bureau;
                Funded by: FundRef NO. AHJZJX-GG2022-003, Anhui Spinal Deformities Clinical Medical Research Center;
                Categories
                Original Article
                Custom metadata
                © Royal Academy of Medicine in Ireland 2023

                Medicine
                adverse events,fondaparinux,major bleeding,orthopedic surgery or trauma surgery,venous thromboembolism

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