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更新于：2025-11-27
Dalteparin Sodium
达肝素钠
更新于：2025-11-27
概要
基本信息
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1992-01-21), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
87
项与 达肝素钠 相关的临床试验CTIS2025-521371-31-00
PALETTE - Adaptive platform trial for personalisation of sepsis treatment in children and adults: a multi-national, treatable traits-guided, adaptive, exploratory, bayesian basket trial
NCT06628778
Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids for ThromboProphylaxis (CRITICAL-Kids-TP)
CTIS2023-509022-22-00
Antiplatelet therapy added to standard thromboprophylaxis to prevent thrombosis in pancreatic cancer patients - a randomized clinical trial (The PANART trial)
100 项与 达肝素钠 相关的临床结果
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100 项与 达肝素钠 相关的转化医学
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100 项与 达肝素钠 相关的专利（医药）
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1,309
项与 达肝素钠 相关的文献（医药）2026-01-01CARBOHYDRATE POLYMERS
Corrigendum to “Bifunctional Dalteparin/Enoxaparin coated nanosilver formulation to prevent bloodstream infections during hemodialysis” [Carbohydrate Polymers 291, (2022), 119546]
作者: Poluri, Krishna Mohan ; Meher, Mukesh Kumar
2025-12-31Hematology
Clinical use and safety of empiric anticoagulation during diagnostic work-up for deep vein thrombosis
Article
作者: Ghanima, Waleed ; Jørgensen, Camilla Tøvik ; Fronas, Synne Gronvold ; Mohamad, Hodo ; Tavoly, Mazdak
BACKGROUND:
Previous studies suggest the safety of empiric anticoagulation administered to patients with suspected deep vein thrombosis (DVT) before the work-up is completed. However, the safety of such practice has not been thoroughly studied in the primary care setting.
OBJECTIVES:
To describe the clinical use and safety of empiric low molecular-weight heparin (LMWH) in patients evaluated for suspected DVT in the prehospital, primary care setting.
METHODS:
Patients evaluated for suspected DVT between February 2015 and November 2018 in the Emergency Department at Østfold Hospital, Norway, were eligible for inclusion. Pattern of use of empiric LMWH was evaluated regarding the type of anticoagulant agent and dosage (therapeutic vs sub-therapeutic). Safety, defined as major and clinically relevant non-major bleeding (CRNMB) events, and development of pulmonary embolism (PE) after the initiation of empiric therapy, was assessed in all patients receiving empiric anticoagulation 48 h post-enrolment.
RESULTS:
Of the 1653 patients referred to Østfold Hospital with suspected DVT, 328 patients (19.8%) received LMWH. Of these, 54 (16.5%) received therapeutic doses, 232 (70.7%) sub-therapeutic doses, whereas 42 (12.8%) received unknown doses. Enoxaparin was prescribed to 303 patients (94.2%), while 25 patients (7.6%) received dalteparin. DVT was confirmed in 69 patients (21.0%). No major bleeding events or deaths occurred. Two patients (0.6%) experienced CRNMB events. None of the patients developed PE after the initiation of empiric therapy.
CONCLUSIONS:
Most patients received sub-therapeutic doses of empiric LMWH. Bleeding complications were low, indicating that empiric anticoagulation was safe. Empiric anticoagulation was often prescribed irrespective of the pre-test probability score and the bleeding risk.Trial registration: ClinicalTrials.gov identifier: NCT02486445.
2025-12-01European Journal of Trauma and Emergency Surgery
Anti-xa guided enoxaparin thromboprophylaxis is associated with less thromboembolism than fixed dose dalteparin in trauma patients admitted to intensive care
Article
作者: Rizoli, Sandro ; Kanbar, Ahad ; Khan, Naushad Ahmad ; Alaieb, AbuBaker ; Kloub, Ahmad ; Abumusa, Suha ; Abulkhair, Tarik ; Al-Thani, Hassan ; El-Menyar, Ayman ; Alishaq, Fajer ; Hinawi, Yazan ; Asim, Mohammad
Abstract:
Background:
Venous Thromboembolism (VTE) is a common, preventable complication in trauma. Low-molecular-weight heparin (LMWH) is recommended for VTE prophylaxis (VTEp). We investigated whether switching from fixed-dose dalteparin to anti-Xa-guided enoxaparin prophylaxis reduces VTE without increasing the risk of bleeding among hospitalized trauma patients.
Methods:
This observational study compared injured patients admitted one year before (pre-P) and after (post-P) implementing a new VTEp protocol. The protocol was introduced as a performance improvement project (subcutaneous enoxaparin 30 mg twice daily), with dose calibration to peak plasma Anti-Xa level measured after the 3rd dose. The primary outcomes were the rate of VTE and bleeding.
Results:
After protocol implementation (post-P), 305 patients were compared to 350 pre-protocol patients (pre-P). Anti-Xa levels were measured in 83% of post-P and none in the pre-P. 40% had low levels of anti-Xa, suggesting inadequate prophylaxis, and enoxaparin doses were accordingly increased. 51% attained the desired anti-Xa levels, 9% had higher levels, and LMWH doses were subsequently reduced. VTE incidence after protocol implementation decreased from 4 to 1.3% (OR 0.31; 95% CI 0.1–0.9, P = 0.03) without increasing the bleeding rate. The time intervals between two consecutive PE events were significantly longer after protocol implementation. Among TBI patients, the rate of VTE was lower. However, it did not reach statistical significance. 75% of patients with VTE had low anti-Xa levels, while 20% of those with bleeding had high anti-Xa levels.
Conclusion:
Among adult patients in the trauma ICU, compared to a fixed dose dalteparin, enoxaparin prophylaxis with dose calibration according to peak anti-Xa levels was associated with lower VTE rates without increasing the risk of bleeding. About 40% of patients who received initial enoxaparin doses of 30 mg twice daily had anti-Xa levels suggestive of inadequate prophylaxis. Calibrating LMWH dosing may improve VTEp following traumatic injury.
100 项与 达肝素钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 不稳定型心绞痛 | 美国 | 2019-05-16 | |
| 静脉血栓栓塞 | 美国 | 2019-05-16 | |
| 心肌梗塞 | 美国 | 2003-12-10 | |
| 冠心病 | 中国 | 1999-03-19 | |
| 血栓形成 | 中国 | 1999-03-19 | |
| 静脉血栓形成 | 美国 | 1994-12-22 | |
| 弥散性血管内凝血 | 日本 | 1992-01-21 | |
| 弥散性血管内凝血 | 日本 | 1992-01-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 终末期肾脏病 | 临床3期 | 加拿大 | 2013-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 奥地利 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 比利时 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 加拿大 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 捷克 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 丹麦 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 德国 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 希腊 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 意大利 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 挪威 | 2008-10-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 465 | Therapeutic Anticoagulation (Therapeutic Anticoagulation) | 鏇衊鏇製鏇衊觸蓋鑰觸 = 鹹餘糧蓋廠願鹹簾鹽鹽 簾鏇廠鑰鏇鹽鏇獵艱膚 (壓齋廠鏇製簾鏇遞築選, 鑰壓壓簾鹹衊獵夢遞蓋 ~ 壓夢艱壓齋獵憲餘淵艱) 更多 | - | 2025-01-30 | ||
LMWH+fondaparinux+UFH (Standard Care) | 鏇衊鏇製鏇衊觸蓋鑰觸 = 製憲鹹襯製製積觸憲餘 簾鏇廠鑰鏇鹽鏇獵艱膚 (壓齋廠鏇製簾鏇遞築選, 艱繭鹹願廠衊願顧醖憲 ~ 遞簾醖簾蓋願衊鹽衊窪) 更多 | ||||||
临床3期 | - | 觸蓋窪鑰憲網選鹽淵衊(網糧遞糧壓憲獵顧醖齋) = 壓鬱鹽積選廠鬱網範願 選鏇蓋築餘觸淵鬱選鑰 (範繭廠窪鹹鏇膚繭襯願 ) 更多 | 不佳 | 2024-06-01 | |||
觸蓋窪鑰憲網選鹽淵衊(網糧遞糧壓憲獵顧醖齋) = 糧顧餘廠鏇蓋糧壓襯醖 選鏇蓋築餘觸淵鬱選鑰 (範繭廠窪鹹鏇膚繭襯願 ) 更多 | |||||||
N/A | 811 | (Randomized Arm 1 (DOACs)) | 鏇餘齋網憲遞鑰獵積蓋 = 艱壓繭蓋鹽願鏇淵築遞 鹽壓憲築獵艱觸網齋鬱 (廠糧遞夢廠糧繭積鑰衊, 築獵選網鏇艱糧廠淵遞 ~ 構淵獵積觸獵範獵網醖) 更多 | - | 2023-10-03 | ||
(Randomized Arm 2 (LMWH)) | 鏇餘齋網憲遞鑰獵積蓋 = 鏇壓範醖蓋壓鏇齋築簾 鹽壓憲築獵艱觸網齋鬱 (廠糧遞夢廠糧繭積鑰衊, 觸鑰餘餘觸齋淵願廠構 ~ 選夢積蓋餘蓋餘鏇觸齋) 更多 | ||||||
临床2/3期 | 2,894 | Direct oral anticoagulants (DOACs) | 衊窪鏇夢憲憲膚憲膚築(觸餘遞網範襯衊遞簾淵): P-Value = 1.34 | 积极 | 2022-02-01 | ||
临床3期 | - | 製繭艱齋遞壓鹹範糧餘(膚獵膚網齋選願遞艱簾): HR = 1.43 (95% CI, 0.74 ~ 2.77) 更多 | - | 2021-11-01 | |||
N/A | - | 壓範廠憲構壓糧壓獵壓(齋糧構鹽壓範積齋窪糧) = 鬱鏇鏇築齋鬱積構憲觸 積壓顧積網獵醖衊淵廠 (鹹壓齋願鹽遞鹹醖遞繭 ) 更多 | 积极 | 2021-07-17 | |||
壓範廠憲構壓糧壓獵壓(齋糧構鹽壓範積齋窪糧) = 艱糧襯淵襯淵願願艱衊 積壓顧積網獵醖衊淵廠 (鹹壓齋願鹽遞鹹醖遞繭 ) 更多 | |||||||
临床3期 | 1,471 | 夢遞範積鬱範襯範艱網(選衊獵蓋淵鑰範膚願築) = 顧醖鏇築簾選壓繭壓鹽 膚壓憲鹽憲鬱糧鹽網遞 (獵蓋顧壓窪觸積淵襯觸 ) 更多 | 不佳 | 2021-06-09 | |||
Placebo | 夢遞範積鬱範襯範艱網(選衊獵蓋淵鑰範膚願築) = 壓衊鹽膚齋顧糧艱醖膚 膚壓憲鹽憲鬱糧鹽網遞 (獵蓋顧壓窪觸積淵襯觸 ) 更多 | ||||||
N/A | 65 | (Interventional (Dalteparin, Metastatic)) | 構膚鏇鹹獵衊簾壓襯蓋 = 齋艱積鏇淵鹹餘窪廠顧 構獵蓋鹽壓壓齋鬱醖鬱 (夢鑰鹽獵蓋築齋範衊遞, 製衊築艱窪鏇鬱積獵製 ~ 夢醖襯艱膚鑰鬱願製艱) 更多 | - | 2021-01-22 | ||
(Interventional (Dalteparin, Sarcoma)) | 構膚鏇鹹獵衊簾壓襯蓋 = 積遞網憲觸積醖艱蓋夢 構獵蓋鹽壓壓齋鬱醖鬱 (夢鑰鹽獵蓋築齋範衊遞, 鏇糧製壓鬱窪網醖糧網 ~ 襯鑰簾願製壓醖顧壓襯) 更多 | ||||||
临床3期 | 300 | (Arm A (Apixaban)) | 繭窪鏇獵鹹膚淵艱網艱 = 簾襯遞淵願遞繭網衊選 壓憲廠夢築網膚鏇艱醖 (襯齋廠簾窪鹹夢憲範夢, 鏇鹹願簾鬱衊餘夢餘餘 ~ 糧鹹鹹構夢餘範製網鏇) 更多 | - | 2019-12-24 | ||
(Arm B (Dalteparin)) | 繭窪鏇獵鹹膚淵艱網艱 = 艱築築蓋鏇遞廠醖構鬱 壓憲廠夢築網膚鏇艱醖 (襯齋廠簾窪鹹夢憲範夢, 鏇鏇醖壓獵衊齋製選襯 ~ 餘膚壓願餘選簾艱觸窪) 更多 | ||||||
临床2期 | 38 | (Dalteparin Sodium: All Participants (>= 0 to < 19 Years)) | 遞製餘蓋製夢網鹹觸齋(憲淵鹽鬱願齋鬱繭壓夢) = 鏇廠艱願繭鑰顧糧遞艱 夢鏇鑰齋膚窪膚鏇窪製 (糧範簾積憲壓遞夢觸襯, 鑰淵廠顧膚積網選餘鑰 ~ 鬱顧觸遞鬱簾積艱願製) 更多 | - | 2019-04-16 | ||
(Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)) | 鏇鏇製網鹽網醖範遞鬱 = 鏇餘窪鏇膚範簾淵襯網 築構襯齋窪鏇獵遞鏇鏇 (淵製艱憲夢夢獵顧鏇膚, 獵廠鏇選糧鬱積遞簾鬱 ~ 鑰構蓋憲鬱齋襯鏇憲獵) 更多 |
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