Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis A… (NCT04730856) | Clinical Trial Compass
CompletedNot Applicable
Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID-19 Pneumonia (PROTHROMCOVID)
Spain311 participantsStarted 2021-02-01
Plain-language summary
The main objective is to evaluate the efficacy and safety of three doses of tinzaparin (prophylactic, intermediate and therapeutic) in hospitalized patients with COVID-19 pneumonia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients admitted to hospital with COVID-19, PCR and/or Antigens Test + SARS-CoV-2 infection or (presence of infiltrate compatible with Chest X-ray or TC)
✓. Patients with, at least, one of the following evolution disease risk criteria:
✓. Age \> 18 years
✓. Weight 50-100 Kg
✓. After receiving oral and written information about the study, patient must give Informed Consent duly signed and dated before performing any activity related to the study.
Exclusion criteria
✕. Patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to ICU at the moment of randomization.
✕. Current diagnosis of acute bronchial asthma attack.
✕. History or clinical suspicion of pulmonary fibrosis.
✕. Current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis.
✕. Patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation.
✕. Patients with pneumonectomy or lobectomy.
✕. Renal failure with Glomerular filtration \<30 ml/min/1.73m2
✕
What they're measuring
1
Combined variable that includes outcomes 2, 3 and 4 detailed below
Timeframe: 30 days
2
Reduction of suspicion of systemic thrombotic symptomatic events
Timeframe: 30 days
3
Use of Mechanical ventilation invasive or non invasive including high flow nasal cannula oxigen