Coronavirus Disease (COVID)19 Clinical Trial
Official title:
D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia
evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | October 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center | Cairo | Non-US |
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mortality | All cause mortality | Until patient is discharged or up to 4 weeks whichever comes first | |
| Primary | occurrence of venous and/or arterial thrombosis | 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) | Until patient is discharged or up to 4 weeks whichever comes first | |
| Secondary | occurrence of Sepsis-induced coagulopathy | calculation of sepsis induced coagulopathy (SIC) score | Until patient is discharged or up to 4 weeks whichever comes first | |
| Secondary | Occurrence of adult respiratory distress syndrome (ARDS) | Calculation of partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/ FIO2) ratio | Until patient is discharged or up to 4 weeks whichever comes first | |
| Secondary | Occurrence of sepsis | Calculation of sequential organ failure (SOFA) score | Until patient is discharged or up to 4 weeks whichever comes first | |
| Secondary | ICU admission and need for mechanical ventilation | occurrence of respiratory failure detected by arterial blood gases analysis | Until patient is discharged or up to 4 weeks whichever comes first |