Coronavirus Disease (COVID)19
Conditions
Brief summary
evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.
Detailed description
The following will be done for enrolled patients: 1. Data collection: name, age, sex, special habits of medical importance (i.e. smoking, drug abuse), comorbid conditions. 2. Clinical examination Vital data Local chest examination 3. Measurement of oxygen saturation using pulse oximeter 4. 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
Interventions
low-molecular-weight heparin administered via subcutaneous injection
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactAshraf Madkour
Outcome results
None listed