D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia
Study Details
Study Description
Brief Summary
evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Detailed Description
The following will be done for enrolled patients:
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Data collection: name, age, sex, special habits of medical importance (i.e. smoking, drug abuse), comorbid conditions.
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Clinical examination Vital data Local chest examination
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Measurement of oxygen saturation using pulse oximeter
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Laboratory investigations:
Complete blood count with differential count Liver and kidney functions D-dimer level Coagulation profile
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Radiology work up ( Chest X-ray-High resolution computed tomography of the chest- computed tomography of the chest with pulmonary angiography as needed)
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Sepsis-induced coagulopathy score (SIC score)
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Sequential organ failure score (SOFA score)
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Patients will receive treatment according to the hospital guidelines for different disease stratification severity
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: 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 |
Drug: low-molecular-weight heparin
low-molecular-weight heparin administered via subcutaneous injection
Other Names:
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Experimental: 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 |
Drug: low-molecular-weight heparin
low-molecular-weight heparin administered via subcutaneous injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- mortality [Until patient is discharged or up to 4 weeks whichever comes first]
All cause mortality
- occurrence of venous and/or arterial thrombosis [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)
Secondary Outcome Measures
- occurrence of Sepsis-induced coagulopathy [Until patient is discharged or up to 4 weeks whichever comes first]
calculation of sepsis induced coagulopathy (SIC) score
- Occurrence of adult respiratory distress syndrome (ARDS) [Until patient is discharged or up to 4 weeks whichever comes first]
Calculation of partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/ FIO2) ratio
- Occurrence of sepsis [Until patient is discharged or up to 4 weeks whichever comes first]
Calculation of sequential organ failure (SOFA) score
- ICU admission and need for mechanical ventilation [Until patient is discharged or up to 4 weeks whichever comes first]
occurrence of respiratory failure detected by arterial blood gases analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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Patients with absolute contraindication of pharmacological thromboprophylaxis and/ anticoagulation
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Congenital hemorrhagic disorders
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Hypersensitivity to heparin
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Personal history of heparin-induced thrombocytopenia
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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).
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Suspected or confirmed bacterial endocarditis
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Ongoing or planned therapeutic anticoagulation for any other indication
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Platelet count <50,000/μL within the past 24 hours or Hb level <8g/dL
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Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
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Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
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Fibrinogen <2.0 g/L
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Severe renal impairment (CrCl<30 mL/min) or acute kidney injury
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Use of dual antiplatelet therapy
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Pregnancy
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Unwillingness to consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center | Cairo | Non-US | Egypt | 11566 |
Sponsors and Collaborators
- Ain Shams University
Investigators
- Principal Investigator: Ashraf Madkour, Ain Shams University, Faculty of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FMASU P35/ 2020