EUCTR2020-005763-31-IT进行中（未招募）1 期
FREEDOM COVID Anticoagulation Strategy Randomized Trial - FREEDOM COVID
INTERVENTIONAL CARDIOVASC. RESEARCH & CLINICAL TRIALS AT ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI0 个研究点目标入组 3,600 人开始时间: 2021年3月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,600
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
- •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
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
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 admission
- •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, including:
- •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 months
- •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 > 120 mmHg)
- •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 agents including but not limited to ticagrelor, prasugrel, and aspirin> 100mg, or non-steroidal anti-inflammatory drugs (e.g. ibuprofen, naproxyn, etc.) due to increased risk of bleeding, unless such agents can be permanently discontinued (aspirin <= 100mg and clopidogrel <=75mg is permitted)
- •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 dialysis
- •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 severe chronic 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. Note: Patients who are unable to give informed consent because of their acute illness may enter the trial if consent is provided by a legally authorized representative.
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