covid-19 acute respiratory distress syndrome
Conditions
Interventions
Patients will be randomized in a 1: 1 ratio between two groups through a digital application.
Group 1) Full heparinization with enoxaparin: Full heparinization will be performed with enoxaparin adjust
Drug
Sponsors
Faculdade de Medicina de Ribeirão Preto
Faculdade de Medicina de Ribeirão Preto
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age above or equal to 18 years; SARS-covid-19 infection confirmed through RT-PCR; Severe forms confirmed by the presence of ARDS according to the Berlin classification ( bilateral infiltrate on chest X-ray, arterial hypoxemia with a PaO2 / FIO2 ratio 24 ipm and saturation <90% after the administration of supplemental oxygen through a nasal catheter at 4 liters / min; Dosage of D-dimer greater than and equal to 0.5 pg / ml; Presence of prothrombin time (TP / INR) <1.5 and APTT (activated partial thromboplastin time (APTT) <1.5; Platelet count greater than 100,000 / mm3
Exclusion criteria
Exclusion criteria: Age over 85 years; creatinine clearance <10 ml / min; severe circulatory shock with a dose of norepinephrine greater than 1.0 pg / Kg / min; Chronic renal patients on hemodialysis; chronic Child B and C liver disease; advanced diseases (active neoplasia, heart failure functional class III and IV, COPD in chronic use of oxygen with more than 2 exacerbations in the last year, advanced dementia, bedridden patient with significant sequelae of stroke or traumatic brain injury; cardiorespiratory arrest; pregnant women; recent major surgery in the last 3 weeks; recent stroke in the last 3 months; presence of active bleeding; presence of blood dyscrasia such as: hemophilia, Von Willebrand factor deficiency, etc.; participation in another clinical investigation with associated intervention; formal indication for oral anticoagulation for other reasons such as: pulmonary embolism, acute coronary syndrome, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of gas exchange between D0 / D4 /D7 /D14 evaluated through the PO2 / FIO2 ratio; days without mechanical ventilation (within 28 days of follow-up, how many days were out of mechanical ventilation, if the patient dies before 28 days of follow-up, it is considered that he did not stay any day out of mechanical ventilation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of plasma D-dimer levels between days D0 / D4; Evaluation of circulating levels of the biomarkers of endothelial glycocalyx lesion (syndecan-1; hyalurane; thrombomodulin; CD44s) between D0 / D4; endothelial glycocalyx thickness assessment assessed by sublingual microscopy using the Glycocheck equipment between D0 / D4 /D7 /D14; assessment of organ dysfunction assessed using the SOFA score (Sequential Organ Failure Assessment Score) between D0 / D4; overall 28-day mortality | — |
Countries
Brazil
Contacts
Public ContactCarlos Miranda
Faculdade de Medicina de Ribeirão Preto
Outcome results
None listed