NL-OMON24892招募中不适用
Rivaroxaban versus low-molecular weight heparin prior to scheduled Ultrasound evaluatioN in patients with suspected Deep Vein Thrombosis
Zuyderland MC0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
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
入选标准
- •We will include patients > 18 years in whom acute DVT of the lower extremity is suspected by their general practitioner based on either a high Wells score or positive D-dimer testing who were referred to Zuyderland MC for further evaluation and whom received pre-emptive anticoagulation (DOAC or LMWH) from their general practitioner.
排除标准
- •-Patients suspected for symptomatic pulmonary embolism or DVT of the upper extremity (in these patients urgent evaluation is indicated, which should not be deferred to the next day).
- •-Patients not receiving pre-emptive anticoagulation either due to violation of the clinical protocol or because of a contra-indication according to the currently used clinical protocol, for example because of:
- •-Current use of anticoagulant drugs (DOACs, LMWHs, or vitamin-K antagonists). The use of antiplatelet drugs (aspirin, clopidogrel etc.) is allowed.
- •-Patients with a very high bleeding risk (as judged by the general practitioner or internist) which is considered to be a contra-indication for pre-emptive use of anticoagulation. For example in case of active major bleeding (e.g. 2 units of more blood or blood products transfused in 24 hours), recent clinically significant bleeding (within the last 7 days); thrombocytopenia (platelets less than 20 x 10^9/L), surgical procedure with high bleeding risk within in the last two weeks (e.g. head and neck surgery, neurosurgery or eye surgery), uncontrolled systolic hypertension (230/120 mmHg or higher). Exclusion is always allowed if bleeding risk is considered to be unacceptably high for other, unmentioned reasons.
- •-Pregnancy or breast feeding.
- •-Clinically significant liver disease (acute hepatitis, cirrhosis etc.).
- •-Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole) or inducers (e.g., rifampicin, carbamazepine, or phenytoin).
- •-Hypersensitivity to the active substance or to any of the excipients
研究者
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