ATTAC-Co: Pro-thrombotic Status in Patients With SARS-Cov-2 Infection
Study Details
Study Description
Brief Summary
The present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Preliminary evidences suggested that patients with SARS-Cov-2 infection and concomitant presence of cardiovascular risk factors (i.e. arterial hypertension) and/or cardiovascular history (i.e. prior myocardial infarction) are at poor prognosis. The first reports from China suggested in patients with SARS-Cov-2 infection a heightened inflammatory burden associated with significant changes in coagulative status (i.e. low platelet count, increased D-dimer) and dysfunction of micro-vessels in pulmonary circulation.
No data are available about patterns and changes in platelet reactivity, activation of coagulation factors and endothelial function during SARS-Cov-2 infection.
The present study is ideated to fill this gap. Patients with moderate to severe respiratory failure due to SARS-Cov-2 infection will be enrolled. One blood sample will be obtained from each patient at the early, mid and late stage of disease. Several markers of platelet, coagulation and endothelial function will be related with laboratory, clinical, electrocardiographic, imaging (transthoracic echocardiogram, pulmonary ultrasonography, computed tomography) and outcome data.
To better describe typical patterns of disease regarding inflammation, platelet function and coagulation alteration, data from cases will be compared with control groups negative for SARS-CoV-2 infection, but with ST-segment elevation myocardial infarction or moderate-severe respiratory failure due to other agents.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: SARS-Cov-2 infection Single study group of patients with respiratory failure due to SARS-Cov-2 infection. Three blood samples will be collected at different stages of disease: early, defined as first 96 hours, mid, defined as time from 96 hours and 14 days, late. defined as >14 days |
Other: SARS-Cov-2 infection
blood sample withdrawal
|
Outcome Measures
Primary Outcome Measures
- on-treatment platelet reactivity [early stage of disease (first 96 hours)]
patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
- on-treatment platelet reactivity [mid stage of disease (96 hours - 14 days)]
patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
- on-treatment platelet reactivity [late stage of disease (>14 days)]
patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
Secondary Outcome Measures
- apoptosis rate in human umbilical vein endothelial cells (HUVEC) [early stage of disease (first 96 hours)]
patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.
- apoptosis rate in human umbilical vein endothelial cells (HUVEC) [mid stage of disease (96 hours - 14 days)]
patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.
- Nitric oxide (NO) intracellular levels [late stage of disease (>14 days)]
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
- Nitric oxide (NO) intracellular levels [early stage of disease (first 96 hours)]
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
- Nitric oxide (NO) intracellular levels [mid stage of disease (96 hours - 14 days)]
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
- reactive oxygen species (ROS) levels [early stage of disease (first 96 hours)]
patterns and changes of ROS
- reactive oxygen species (ROS) levels [mid stage of disease (96 hours - 14 days)]
patterns and changes of ROS
- reactive oxygen species (ROS) levels [late stage of disease (>14 days)]
patterns and changes of ROS
- coagulation factors levels [early stage of disease (first 96 hours)]
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
- coagulation factors levels [mid stage of disease (96 hours - 14 days)]
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
- coagulation factors levels [late stage of disease (>14 days)]
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
- respiratory function [6-month]
values of FEV1% as assessed by spirometry
- respiratory function [12-month]
values of FEV1% as assessed by spirometry
- cardiac function [6-month]
values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
- cardiac function [12-month]
values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
- clinical outcome [12-month]
occurrence of death, myocardial infarction, stroke and other major adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of moderate-severe respiratory failure (PaO2/FiO2 <200)
-
Diagnosis of SARS-CoV-2 infection + one of the following
-
invasive mechanical ventilation (cohort A)
-
non invasive mechanical ventilation (cohort B)
-
only oxygen support
Exclusion Criteria:
-
Previous chronic use of P2Y12 inhibitors
-
Need for chronic oral anti-coagulation therapy
-
Know disorder of coagulation or platelet function
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera Universitaria di Ferrara | Ferrara | Italy |
Sponsors and Collaborators
- University Hospital of Ferrara
Investigators
- Principal Investigator: Savino Spadaro, MD, Intensive care unit
- Principal Investigator: Gianluca Campo, MD, Cardiology Unit
- Principal Investigator: Marco Contoli, MD, Pulmonology Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 250320