D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.
详细描述
The following will be done for enrolled patients:
- Data collection: name, age, sex, special habits of medical importance (i.e. smoking, drug abuse), comorbid conditions.
- Clinical examination Vital data Local chest examination
- Measurement of oxygen saturation using pulse oximeter
- Laboratory investigations:
Complete blood count with differential count Liver and kidney functions D-dimer level Coagulation profile 5. Radiology work up ( Chest X-ray-High resolution computed tomography of the chest- computed tomography of the chest with pulmonary angiography as needed) 6. Sepsis-induced coagulopathy score (SIC score) 7. Sequential organ failure score (SOFA score) 8. Patients will receive treatment according to the hospital guidelines for different disease stratification severity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult (>18 years) patients from both sexes with COVID-19 pneumonia with positive nucleic acid test for severe acute respiratory syndrome Coronavirus (SARS-CoV-2) hospitalized either in the ward or intensive care unit
排除标准
- •Patients with absolute contraindication of pharmacological thromboprophylaxis and/ anticoagulation
- •Congenital hemorrhagic disorders
- •Hypersensitivity to heparin
- •Personal history of heparin-induced thrombocytopenia
- •Active major bleeding or conditions predisposing to major bleeding. Major bleeding is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g.intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level (Hb) of ≥2g/dL in a 24h period, or c) leads to transfusion of 2 or more units of whole blood or red blood cells (13).
- •Suspected or confirmed bacterial endocarditis
- •Ongoing or planned therapeutic anticoagulation for any other indication
- •Platelet count <50,000/μL within the past 24 hours or Hb level <8g/dL
- •Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
- •Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
- •Fibrinogen <2.0 g/L
- •Severe renal impairment (CrCl<30 mL/min) or acute kidney injury
- •Use of dual antiplatelet therapy
- •Pregnancy
- •Unwillingness to consent
研究组 & 干预措施
Therapeutic dose low-molecular-weight heparin (LMWH)
Therapeutic dose low-molecular-weight heparin from admission until the end of hospital stay Enoxaparin 1 mg/kg subcutaneous every 12 hours
干预措施: low-molecular-weight heparin (Drug)
D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy
from admission until the end of hospital stay. Patients will be stratified according to their body weight and D-dimer level and receive LMWH
D-Dimer level Body Weight LMWH dose
<1 mg/dl <100kg Enoxaparin 40mg OD 100-150kg Enoxaparin 40mg BD >150kg Enoxaparin 60mg BD
1-3 mg/ dl <100kg Enoxaparin 40mg BD 100-150kg Enoxaparin 80mg BD >150kg Enoxaparin 120mg BD
>3 mg/ dl Enoxaparin 80mg BD
干预措施: low-molecular-weight heparin (Drug)
结局指标
主要结局
mortality
时间窗: Until patient is discharged or up to 4 weeks whichever comes first
All cause mortality
occurrence of venous and/or arterial thrombosis
时间窗: Until patient is discharged or up to 4 weeks whichever comes first
clinical signs supported by radiological evidence of arterial thrombosis or venous thromboembolism (e.g. venous or arterial duplex and CT scan of the chest with pulmonary angiography)
次要结局
- occurrence of Sepsis-induced coagulopathy(Until patient is discharged or up to 4 weeks whichever comes first)
- Occurrence of adult respiratory distress syndrome (ARDS)(Until patient is discharged or up to 4 weeks whichever comes first)
- Occurrence of sepsis(Until patient is discharged or up to 4 weeks whichever comes first)
- ICU admission and need for mechanical ventilation(Until patient is discharged or up to 4 weeks whichever comes first)
研究者
Ashraf M Madkour
Professor
Ain Shams University