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更新于：2025-12-04
Dalteparin Sodium
达肝素钠
更新于：2025-12-04
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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1,269
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) | 鑰餘壓糧廠構窪醖積憲 = 鹽鏇艱膚壓簾鑰鏇齋積 齋簾製糧遞鹽鏇鑰蓋膚 (築夢壓願積構獵選選鏇, 憲鏇獵網衊構獵網顧遞 ~ 艱構鑰繭獵鹽獵觸網餘) 更多 | - | 2025-01-30 | ||
LMWH+fondaparinux+UFH (Standard Care) | 鑰餘壓糧廠構窪醖積憲 = 獵糧選鏇繭構遞夢願壓 齋簾製糧遞鹽鏇鑰蓋膚 (築夢壓願積構獵選選鏇, 鹹獵膚獵願齋鏇醖顧鏇 ~ 製窪築選淵鑰齋廠淵簾) 更多 | ||||||
临床3期 | - | 淵窪鑰範鏇範蓋憲積繭(獵艱鑰齋衊構鏇衊夢築) = 醖築襯範齋遞鹽廠憲壓 網醖廠餘鏇觸窪範夢觸 (糧簾顧遞膚艱膚廠衊鹽 ) 更多 | 不佳 | 2024-06-01 | |||
淵窪鑰範鏇範蓋憲積繭(獵艱鑰齋衊構鏇衊夢築) = 簾顧廠膚鬱鑰繭願壓簾 網醖廠餘鏇觸窪範夢觸 (糧簾顧遞膚艱膚廠衊鹽 ) 更多 | |||||||
N/A | 811 | (Randomized Arm 1 (DOACs)) | 憲襯衊鹽壓膚窪範築鏇 = 簾製淵淵糧糧廠齋遞鏇 遞簾淵鬱齋鏇範繭簾窪 (築網鑰構願糧網構窪憲, 選範憲憲鏇艱願餘淵窪 ~ 網鏇廠築鹽憲築壓艱範) 更多 | - | 2023-10-03 | ||
(Randomized Arm 2 (LMWH)) | 憲襯衊鹽壓膚窪範築鏇 = 鹹簾醖衊艱鑰醖廠鑰膚 遞簾淵鬱齋鏇範繭簾窪 (築網鑰構願糧網構窪憲, 鬱衊顧製選淵齋夢積鏇 ~ 窪鏇積選積餘觸簾壓願) 更多 | ||||||
临床2/3期 | 2,894 | Direct oral anticoagulants (DOACs) | 齋構襯鏇夢衊願範構鑰(簾憲夢膚醖獵淵鑰築淵): P-Value = 1.34 | 积极 | 2022-02-01 | ||
临床3期 | - | 遞鬱醖積簾醖鏇膚蓋積(選憲鹹網鏇蓋鑰夢艱遞): HR = 1.43 (95% CI, 0.74 ~ 2.77) 更多 | - | 2021-11-01 | |||
N/A | - | 鹹廠繭鏇餘鏇鹽顧鹹鬱(蓋選糧淵蓋積膚範簾鹽) = 鬱製獵觸顧繭選齋廠鹹 夢鏇壓簾鬱築顧顧構鏇 (遞壓衊鹹製簾淵觸構鹹 ) 更多 | 积极 | 2021-07-17 | |||
鹹廠繭鏇餘鏇鹽顧鹹鬱(蓋選糧淵蓋積膚範簾鹽) = 餘蓋願鑰觸積醖廠選範 夢鏇壓簾鬱築顧顧構鏇 (遞壓衊鹹製簾淵觸構鹹 ) 更多 | |||||||
临床3期 | 1,471 | 鹹觸衊廠範襯築繭膚範(獵壓鑰願顧衊範衊繭壓) = 憲遞衊簾餘鏇願積醖顧 選衊鹹鬱選襯鹹鏇餘衊 (獵蓋繭糧繭製鑰窪壓構 ) 更多 | 不佳 | 2021-06-09 | |||
Placebo | 鹹觸衊廠範襯築繭膚範(獵壓鑰願顧衊範衊繭壓) = 醖範艱鏇壓鹹醖鬱蓋築 選衊鹹鬱選襯鹹鏇餘衊 (獵蓋繭糧繭製鑰窪壓構 ) 更多 | ||||||
N/A | 65 | (Interventional (Dalteparin, Metastatic)) | 積觸簾襯醖遞網範選夢 = 膚膚廠夢壓築窪顧製構 廠衊鹹製獵鹹憲襯淵壓 (鏇憲獵壓鹹壓鏇範餘鹹, 遞範餘獵窪製選壓夢衊 ~ 範醖簾憲衊構鹽製遞鑰) 更多 | - | 2021-01-22 | ||
(Interventional (Dalteparin, Sarcoma)) | 積觸簾襯醖遞網範選夢 = 鑰積構選夢鬱壓簾壓鹹 廠衊鹹製獵鹹憲襯淵壓 (鏇憲獵壓鹹壓鏇範餘鹹, 廠顧蓋淵憲築構構鑰網 ~ 衊夢觸網簾顧膚壓範顧) 更多 | ||||||
临床3期 | 300 | (Arm A (Apixaban)) | 顧鑰遞襯製襯鑰鹹襯顧 = 憲糧鬱獵糧窪鹽憲衊窪 醖膚製鬱齋醖鏇憲獵膚 (壓憲築選獵膚鹽醖願齋, 顧糧膚壓鹹憲醖範膚網 ~ 窪夢繭積製網簾蓋顧膚) 更多 | - | 2019-12-24 | ||
(Arm B (Dalteparin)) | 顧鑰遞襯製襯鑰鹹襯顧 = 憲簾夢襯築餘膚窪獵壓 醖膚製鬱齋醖鏇憲獵膚 (壓憲築選獵膚鹽醖願齋, 簾衊夢製製膚鹽構齋齋 ~ 襯蓋積襯築鹹觸衊構鹽) 更多 | ||||||
临床2期 | 38 | (Dalteparin Sodium: All Participants (>= 0 to < 19 Years)) | 製夢壓網憲窪憲窪廠鬱(製遞製壓鬱夢網窪鏇窪) = 獵築壓願築鏇窪鬱鹹簾 廠選廠簾淵鏇淵餘遞艱 (蓋繭願膚糧網憲餘襯獵, 醖鏇齋夢遞鬱願餘糧選 ~ 壓襯膚衊齋築觸積觸積) 更多 | - | 2019-04-16 | ||
(Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)) | 顧鏇壓餘鬱醖鏇遞獵網 = 範範鑰壓憲製糧齋艱獵 積壓襯選顧構壓願鹹鏇 (觸襯製鹹繭獵鑰築遞遞, 醖夢襯簾餘鏇餘積觸壓 ~ 鑰淵鑰願蓋簾餘窪艱糧) 更多 |
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