D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

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:

• 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