2025-522832-16-00招募中3 期
Intermediate versus standard dose enoxaparin to prevent venous thromboembolism in severe trauma patients: a multicenter double blind randomised controlled trial (HEPTRAUMA)
Centre Hospitalier Universitaire Grenoble Alpes11 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2025年12月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 11
- 主要终点
- Composite of symptomatic deep vein thrombosis, proximal deep vein thrombosis, pulmonary embolism within 14 days following randomisation after severe trauma
研究概览
简要总结
To determine the effect of intermediate versus standard dose low-molecular-weight heparin on the incidence of major venous thromboembolism following severe trauma.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •All adult patients (age ≥18 years) admitted to an intensive care unit following trauma with an expected stay >48 hours and a planned administration of LMWH
- •Affiliation to the French social security system or European (CEAM)
排除标准
- •Prehospital cardiac arrest
- •History of heparin-induced thrombocytopenia
- •Study drug hypersensitivity
- •Limitation of life support, life expectancy ≤7 days or palliative care
- •Contraindication to the administration of anticoagulant according to the SPC (Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent haemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmological surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intrarachid or intracerebral vascular anomalies.)
- •Pregnant or breastfeeding woman
- •Inclusion in another experimental trial
- •Protected person (art. L1121-5 to L1121-8 of the CSP or art. 31 to 35 of European regulation 536/2014)
- •Hospital admission >72 hours
- •More than one dose of prophylactic anticoagulant already administered since trauma
- •Renal failure defined by creatinine clearance of 30 mL/min or less (Cockcroft-Gault formula)
- •Body weight >100 kg or <45 kg
- •Indication for therapeutic anticoagulation
- •Major known thrombophilia (e.g. antiphospholipid syndrome, antithrombin deficiency)
- •Constitutional bleeding disorder (haemophilia, von Willebrand disease, coagulation factor deficiency, platelet disorder).
- •Thrombocytopenia inferior to 50 G.L-1
结局指标
主要结局
Composite of symptomatic deep vein thrombosis, proximal deep vein thrombosis, pulmonary embolism within 14 days following randomisation after severe trauma
Composite of symptomatic deep vein thrombosis, proximal deep vein thrombosis, pulmonary embolism within 14 days following randomisation after severe trauma
次要结局
- Key secondary endpoint (included in a sequential hierarchical testing procedure): Composite of major venous thromboembolism, as defined in the primary endpoint, and major bleedings, defined by (i) the need for a haemostatic invasive procedure because of bleeding, (ii) the need for interruption of prophylactic enoxaparin for ≥48 hours because of bleeding, or (iii) bleeding in a critical organ within 14 days following randomisation after a severe trauma
- Other endpoints: Major or clinically relevant non-major bleeding, as per ISTH definition, occurring during or within 48h of the last dose of study drug; Incidence of major venous thromboembolism (as defined in the primary endpoint) and major bleeding (as per ISTH definition) at day 30 following randomisation; death at day 30 following randomisation
研究者
GODON Alexandre
Scientific
Centre Hospitalier Universitaire Grenoble Alpes
研究点 (11)
Loading locations...
相似试验
已完成
4 期
Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)Atrial FibrillationNCT00289042The Cleveland Clinic200
已完成
不适用
Enoxaparin versus control for venous thromboembolic prophylaxis after total knee arthroplasty in Asian patients: a randomized controlled trialosteoarthritis of kneeknee arthroplastyDVT prophylaxisTCTR20140527001Golden Jubilee Medical Center50
已完成
1 期
Enoxamed Study in the Treatment of Acute Coronary SyndromesAcute Coronary SyndromeNCT02152423University of Monastir50
招募中
3 期
OPTI-TREX - Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients2024-513650-30-00Assistance Publique Hopitaux De Paris50
进行中（未招募）
1 期
ow-molecular-weight heparin to prevent venous thromboembolism in COVID-19 patients : a randomized controlled trial of different dosesPrevention of thromboembolic events in hospitalised COVID-19 infected patientsMedDRA version: 20.0Level: HLGTClassification code 10014523Term: Embolism and thrombosisSystem Organ Class: 10047065 - Vascular disordersEUCTR2020-001709-21-FRCHRU de Nancy550