CTRI/2020/11/029345招募中4 期
A Phase IV Prospective Multi-Center, Open Label, Randomized Controlled Comparative Study to evaluate the safety and effectiveness of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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
- •1. Hospitalization within the prior 24 hours for either confirmed
- •(based on PCR or antigen positive test for SARS-CoV-2) or
- •suspected COVID-19 based on 3 criteria (all 3 must be
- •present for suspected cases):
- •a. Fever >38 degrees Celsius
- •b. O2 saturation <=94
- •c. Abnormal laboratory marker (at least 1)
- •i. d-dimer >=1.0 μg /mL
- •ii. CRP >2 mg/L
- •iii. Ferritin >300 μg /L
- •iv. Lymphopenia <1500 cells /m3
- •2. Patient or legal guardian provides written informed consent
排除标准
- •1. Age <18 years
- •2. Mechanical ventilation on admission or high likelihood for the
- •need for invasive mechanical ventilation within 24 hours of
- •3. Anticipated duration of hospital stay <72 hours
- •4. Treatment with therapeutic dose UFH or LMWH, vitamin K
- •antagonists, or NOACs within seven days
- •5. Active bleeding
- •6. Risk factors for bleeding
- •a. intracranial surgery or stroke within 3 months
- •b. history of intracerebral arteriovenous malformation
- •c. cerebral aneurysm or mass lesions of the central
- •nervous system
- •d. intracranial malignancy
- •e. history of intracranial bleeding
- •f. history of bleeding diatheses (e.g., hemophilia)
- •g. history of gastrointestinal bleeding within previous 3
- •h. thrombolysis within the previous 7 days
- •i. presence of an epidural or spinal catheter
- •j. recent major surgery <14 days
- •k. uncontrolled hypertension (sBP > 200 mmHg or dBP >
- •l. other physician-perceived contraindications to
- •anticoagulation
- •m. Platelet count <50 x109/L, INR >2.0, or baseline aPTT
- •>50 seconds
- •n. Hemoglobin <80 g/L (to minimize the likelihood of
- •requiring red blood cell transfusion if potential bleeding
- •were to occur)
- •o. current treatment with antithrombotics or antiplatelet
- •7. Acute or subacute bacterial endocarditis
- •8. History of heparin induced thrombocytopenia (HIT) or other
- •heparin allergy including hypersensitivity
- •9. Patients with non-COVID-19 related clinical condition for
- •which life expectancy is <6 months
- •10. Pregnancy (women of childbearing potential are required to
- •have a negative pregnancy test prior to enrollment)
- •11. Active enrollment in other trials related to anticoagulation
- •12. Patients has end stage kidney disease (ESKD) on chronic
- •13. Patient is a member of a vulnerable population: In the
- •judgment of the investigator the patient is unable to give
- •Informed Consent for reasons of incapacity, immaturity,
- •adverse personal circumstances or lack of autonomy. This
- •may include: Individuals with mental disability, persons in
- •nursing homes, children, impoverished persons, persons in
- •emergency situations, homeless persons, nomads, refugees,
- •and those incapable of giving informed consent. Vulnerable
- •populations also may include members of a group with a
- •hierarchical structure such as university students, subordinate
- •hospital and laboratory personnel, employees of the Sponsor,
- •members of the armed forces, and persons kept in detention.
研究者
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