evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.
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
Drug: low-molecular-weight heparin
low-molecular-weight heparin administered via subcutaneous injection
Other Name: Enoxaparin
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
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt
Investigator: Fatma Soliman E Ebeid
Contact: 01095569596
dr.fatma_ebeid@yahoo.com
Ashraf Madkour
+20 100 177 0703
asfrah_madkour@yahoo.com
Ashraf Madkour, Principal Investigator
Ain Shams University, Faculty of Medicine