Acute Respiratory Failure Clinical Trial
Official title:
Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial
Verified date | August 2022 |
Source | University Magna Graecia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Coronavirus Disease (COVID-19) is characterized by a hypercoagulable state, sometimes difficult to be managed with heparin. Bivalirudin, a member of the direct thrombin inhibitor drug class, offers potential advantages compared to heparin, including to its ability to exert its effect by directly attaching to and inhibiting freely circulating and fibrin-bound thrombin. Investigators have therefore designed this pilot open-label randomized controlled trial to assess if a off-label infusion of bivalirudin may reduce thrombosis, mortality, Intensive Care Unit (ICU) length of stay and increase ventilator free days of patients admitted in ICU for acute respiratory failure due to COVID-19, as compared to first-line treatment with heparin.
Status | Completed |
Enrollment | 58 |
Est. completion date | July 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ratio between arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) < 200 mmHg - age equal or greater of 18 years/old - detection of coronavirus 2019 at the nasal swab; - need for endotracheal intubation and invasive mechanical ventilation Exclusion Criteria: - known allergies to one of the two investigated drugs - presence of hematological diseases - pregnancy - recent (10 days) surgery - presence of active bleeding |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Mater Domini | Catanzaro |
Lead Sponsor | Collaborator |
---|---|
University Magna Graecia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time spent under invasive mechanical ventilation | number of days that patient would require invasive mechanical ventilation | from randomization till 28 days after randomization | |
Secondary | Incidence of vein thrombosis and embolism | Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism | from randomization till 28 days after randomization or ICU discharge | |
Secondary | Gas Exchange | Daily evaluation of oxygenation through arterial blood gases | Every day till 28 days after randomization or ICU discharge | |
Secondary | Intensive Care Unit length of stay | Number of days spent in Intensive Care Unit | Up to 1 year | |
Secondary | Intensive Care Unit mortality | Number of patients died during the Intensive Care Unit stay | Up to 1 year |
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