|drug446||Duplex ultrasound and Computed Tomography Angiography Wiki||0.35|
|drug426||Diagnostic examination for venous thromboembolism Wiki||0.35|
|drug1399||Tirofiban Injection Wiki||0.35|
|drug944||Optical Coherence Tomography (OCT) Wiki||0.35|
|drug51||Acetylsalicylic acid Wiki||0.35|
|drug475||Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml Wiki||0.35|
|D011655||Pulmonary Embolism NIH||0.80|
|D016769||Embolism and Thrombosis NIH||0.61|
|D020246||Venous Thrombosis NIH||0.53|
|D054556||Venous Thromboembolism NIH||0.47|
|D011024||Pneumonia, Viral NIH||0.10|
|D016638||Critical Illness NIH||0.07|
|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.03|
There are 8 clinical trials
This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).
Description: Change in ratio between partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, and inspired oxygen fraction at baseline and after study treatmentMeasure: P/F ratio Time: At baseline and 24, 48 and 168 hours after treatment initiation
Description: Change in partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatmentMeasure: PaO2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiation
Description: Change in alveolar-arterial gradient of oxygen at baseline and after study treatment. Arterial alveolar gradient will be calculated using the following parameters derived from arterial blood gas analysis: partial pressure of oxygen in arterial blood and partial pressure of carbon dioxide in arterial blood.Measure: A-a O2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiation
Description: Number of days on continuous positive end expiratory pressure (CPAP)Measure: CPAP duration Time: From the first day of study drugs administration (T0) until day 7 post study drugs administration
Description: Difference in intensity of the respiratory support (non invasive mechanical ventilation, CPAP, high flow nasal cannula (HFNC), Venturi Mask, nasal cannula, from higher to lower intensity, respectively) employed at baseline and at 72 and 168 hours after study treatment initiationMeasure: In-hospital change in intensity of the respiratory support Time: At baseline and 72 and 168 hours after treatment initiation
Description: Difference in partial pressure of carbon dioxide in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatmentMeasure: PaCO2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiation
Description: Difference in concentration of bicarbonate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatmentMeasure: HCO3- difference Time: At baseline and 24, 48 and 168 hours after treatment initiation
Description: Difference in concentration of lactate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatmentMeasure: Lactate difference Time: At baseline and 24, 48 and 168 hours after treatment initiation
Description: Difference in hemoglobin concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.Measure: Hb difference Time: At baseline and 24, 48 and 168 hours after treatment initiation
Description: Difference in platelet concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.Measure: Plt difference Time: At baseline and 24, 48 and 168 hours after treatment initiation
Description: Any major or minor adverse effect occuring during and after the administration of the study drug (e.g. bleeding)Measure: Adverse effects Time: From the first day of study drugs administration until day 30 post study drugs administration
Reports of acute pulmonary embolism (APE) associated with COVID-19 have emerged in the literature. For example, Chen et al. described 25 pulmonary CT angiograms examinations from 1008 COVID-19 patients; 10 were positive for pulmonary embolism mostly as segmental or sub-segmental APE. Case reports of APE in Covid-19 patients have been published. Cui et al. found an incidence of deep venous thrombosis in intensive care unit (ICU) patients with severe Covid-19 pneumonia near to 25% (20/81), however without any correlation with potential APE. Despite these initial reports, it is not clear whether APE is more frequent in Covid-19 patients or if the association is just random. In favor of the former, D-dimer levels have been reported as elevated in patients with Covid-19 by two studies, and it has been suggested an independent association between the severity of the disease and the level of D-dimer. Finally, Tang et al. showed that anticoagulant therapy is associated with a decreased mortality at Day-28 in severe Covid-19 patients, in favor of a possible associated coagulopathy. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.
Worldwide observational studies indicate a significant prothrombogenic effect associated with SARS-CoV-2 infection with a high incidence of venous thromboembolism (VTE), notably life-threatening pulmonary embolism. According to recommendations for acute medical illnesses, all COVID-19 hospitalized patients should be given VTE prophylaxis such as a low molecular weight heparin (LMWH). A standard prophylactic dose (eg. Enoxaparin 4000IU once daily) could be insufficient in obese patients and VTE has been reported in patients treated with a standard prophylactic dose. In COVID-19 patients, guidelines from several international societies confirm the existence of an hypercoagulability and the importance of thromboprophylaxis but the "optimal dose is unknown" and comparative studies are needed. In view of these elements, carrying out a trial comparing various therapeutic strategies for the prevention of VTE in hospitalized patients with COVID-19 constitutes a health emergency. Thus, we hypothesize that an increased prophylactic dose of weight-adjusted LMWH would be greater than a lower prophylactic dose of LMWH to reduce the risk of life-threatening VTE in hospitalized patients. The benefit-risk balance of this increase dose will be carefully evaluated because of bleeding complications favored by possible renal / hepatic dysfunctions, drug interactions or invasive procedures in COVID-19 patients. This multicenter randomized (1:1) open-label controlled trial will randomize hospitalized adults with COVID-19 infection to weight-adjusted prophylactic dose vs. lower prophylactic dose of LMWH.
Description: Risk of deep vein thrombosis or pulmonary embolism or venous thromboembolism-related deathMeasure: Venous thromboembolism Time: 28 days
Description: Risk of major bleeding defined by the ISTHMeasure: Major bleeding Time: 28 days
Description: Risk of Major Bleeding and Clinically Relevant Non-Major Bleeding Defined by the ISTHMeasure: Major Bleeding and Clinically Relevant Non-Major Bleeding Time: 28 days
Description: Risk of Venous Thromboembolism and Major BleedingMeasure: Net Clinical Benefit Time: 28 days and 2 months
Description: Risk of venous thrombosis at other sites: e.g. superficial vein, catheters, hemodialysis access, ECMO, splanchnic, encephalic, upper limbMeasure: Venous Thromboembolism at other sites Time: 28 days
Description: Risk of arterial thrombosis at any sitesMeasure: Arterial Thrombosis Time: 28 days
Description: Risk of all-cause mortalityMeasure: All-Cause Mortality Time: 28 days and 2 months
Description: Identification of associations between the risk of venous thromboembolism and clinical (eg. past medical history of thrombosis, cardiovascular risk factors, treatments, severity of COVID-19) and laboratory variables (e.g. D-dimers, fibrinogen, CRP) collected in the eCRFMeasure: Factors associated with the risk of venous thromboembolism Time: 28 days
Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.
Description: Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"Measure: Venous thromboembolisms Time: 7 days
Description: Deaths from all causes during the follow-upMeasure: Deaths Time: 7 days
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19). Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press). This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation. The main objective is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.
Description: The primary outcome measure will be the percentage of patients with one or more DVTs from a lower extremity ultrasound scan.Measure: percentage of patients with one or more DVTs. Time: 28 days
The OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.
Description: including deep vein thrombosis (including catheter-associated), pulmonary embolism, myocardial infarction/myocarditis, arterial ischemia including mesenteric and extremities, acute splanchnic vein thrombosis, or ischemic strokeMeasure: Number of cardiovascular events Time: within 14 days, 30 days, and 90 days of randomization
Description: measured by number of cardiovascular events, and major bleedingMeasure: Net clinical benefit Time: within 14 days, 30 days, and 90 days of enrolment.
Description: ISTH criteria, in-hospital diagnosisMeasure: Disseminated intravascular coagulation Time: within 14 days, 30 days, and 90 days of enrolment
The purpose of this study is to investigate the prevalence of venous thromboembolism in a regional health care system (Region Östergötland, Sweden) before and during the SARS-COV-2 pandemic. In a retrospective observational study, we will review patient data, diagnostic data and treatment data over a three-month period since the onset of the SARS-COV-2 pandemic. This data will be compared with data from the corresponding time frame during the years 2015 to 2019.
To evaluate by intravascular OCT study the presence of microvascular pulmonary thrombosis in patients with COVID-19, high D-dimer levels and contrast CT scan negative for pulmonary thrombosis. We'll also evaluate the extension of microvascular pulmonary thrombosis in patients with contrast CT scan positive for pulmonary embolism in areas where contrast CT scan was negative.
Description: Study primary endpoints will be evaluation of OCT procedure overall safety in COVID-19 pneumonia patients and assessment of the presence of microvascular pulmonary thrombosis in COVID-19 patients, both in "ground glass" and "healthy" ventilated areas.Measure: optical coherence tomography pulmonary microthrombosis assessment in COVID-19 pneumonia patients Time: through study completion, an average of 1 month
Description: Pulmonary artery vessel anatomy characterization in COVID-19 pneumonia patients through OCT diagnostic technique Correlations with single trans-thoracic echocardiography (TTE) pulmonary hypertension (PH, estimated systolic pulmonary artery pressure > 35 mmHg) and right ventricular disfunction (RVD: tricuspid annular plane systolic excursion < 17 mm or Doppler tissue imaging S wave < 9.5 cm/sec). Dynamic correlations with standard inflammatory, coagulation and tissue damage biomarkers: CRP, ferritin, D-dimer, NT-proBNPO, troponins, LDH)Measure: Pulmonary artery vessel anatomy characterization Time: through study completion, an average of 1 month
Description: Correlations with single trans-thoracic echocardiography (TTE) pulmonary hypertension (PH, estimated systolic pulmonary artery pressure > 35 mmHg) and right ventricular disfunction (RVD: tricuspid annular plane systolic excursion < 17 mm or Doppler tissue imaging S wave < 9.5 cm/sec)Measure: Correlation between TTE pulmonary hypertension and right ventricular disfunction Time: through study completion, an average of 1 month
Description: Pneumonia COVID-19 dynamic correlation with inflammation and coagulation markersMeasure: Correlations with standard inflammatory, coagulation and tissue damage Time: through study completion, an average of 1 month