Full versus prophylactic anticoagulation for the treatment of severe forms of Covid-19:
- Conditions
- covid-19acute respiratory distress syndromeB97.2
- Registration Number
- RBR-949z6v
- Lead Sponsor
- Faculdade de Medicina de Ribeirão Preto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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 <300, absence of structural heart disease or evidence of insufficiency acute cardiac arrest; Presence of severe clinical presentation with respiratory failure requiring orotracheal intubation or mechanical ventilation or maintenance of RF> 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
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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