CTIS2022-502426-41-00招募中1 期
Thromboprophylaxis in good and intermediate prognosis advanced germ cell tumors (GIG-T) - 2022/3510 GIG-T
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 387
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- Male
入选标准
- •1.Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the IGCCCG Group), 2.= 18 years, 3.Suitable for first-line cisplatin-based chemotherapy, 4.No prior systemic cytotoxic therapy, 5.Signed informed consent, 6.Additional criteria for patients who will be randomized, (VTE high-risk patients):o LDH>1UNL and/or , oBSA > 1.9 and/or, o > 5 cm long axis retroperitoneal lymph nodes, 7.Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol., 8.Patients must be affiliated to a social security system or beneficiary of the same
排除标准
- •1.Brain metastasis, 10.Participation in another clinical study with an investigational product during the last 4 weeks, and while on study treatment without the approval from sponsor, 11.Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent, 2.History of VTE, 3.Concomitant use of anticoagulants or antiaggregants, 4.Renal impairment defined as creatinine clearance less than 50 ml/min using Cockcroft-Gault formula, 5.Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients, 6.Any major surgery (i.e. open surgery lasting more than 45 minutes from opening to closure) within 4 weeks or planned during the study treatment period Severe uncontrolled high blood pressure (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg), 7.Low baseline platelet count (< 100 X 10 9 /L) or history of heparin-induced thrombocytopenia, 8.Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities, 9.Extensive metastatic disease at high risk of bleeding, e.g. prevalent choriocarcinoma
研究者
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