EUCTR2004-004722-27-ES进行中（未招募）不适用
Randomised, open, multicenter, sequential trial assessing the safety and efficacy of bemiparin on the response to the treatment in patients diagnosed with localized small cell carcinoma of the lung. - ABEL STUDY
Instituto Científico y Tecnológico de Navarra, S.A.0 个研究点开始时间: 2006年4月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients of both sexes, aged 18 or older, diagnosed with localized small cell carcinoma of the lung.
- •Patients with an ECOG performance status <=2
- •Patients who have given signed informed consent.
- •Patients with a platelet count higher than 100.000 µl and without haemorrhagic symptomatology.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Curative or palliative surgery as a starting treatment of a neoplastic process.
- •Patients with an active haemorrhage within the last two months, organic injuries susceptible to bleeding (ie.: active peptic ulcer, hemorrhagic CVA (Cerebrovascular Accident), aneurysm), antecedents of haemorrhagic episodes clinically significant, major surgery within the last month or increased bleeding risk due to any hemostasis disorders that may contraindicate anticoagulant therapy.
- •Patients with hypersensitivity reactions to low molecular weight heparin (LMWH), heparin or substances of porcine origin.
- •Patients with hipersensitivity reactions to carboplatin and cisplatin, or hipersensitivity reaction to etoposide.
- •Patients with congenital or acquired bleeding diathesis.
- •Possible hurts or surgical interventions located in the central nervous system, eyes and ears within 6 months prior to take part in the trial.
- •Acute bacterial endocarditis and subacute endocarditis.
- •Patients with thrombocytopenia related to heparin or with a current platelet cout <100.000 / mm3
- •Patients with serious renal insufficiency, (creatinine >20 mmol/L and/or serum creatinine > 2mg/L) hepatic failure (with AST and/or ALT values 5 times higher than normal reference ranges).
- •Non-controlled hypertension (PAS >200 mmHg; PAD >120 mmHg).
- •Pregnant or lactation women, or women of childbearing potiential not practicing adequate means of contraception during the trial.
- •Patients unlikely to comply with the protocol requirements
- •Patients who take part in another clinical trial or did it within the last 30 days.
- •Patients with life expectance less than 3 months.
- •Patients who follow a treatment with any anticuagulant or did it within 3 months prior to the tumor diagnosis.
研究者
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