Name (Synonyms) | Correlation | |
---|---|---|
drug392 | Echo-Doppler Wiki | 0.35 |
drug484 | Heparin Infusion Wiki | 0.35 |
drug448 | Fondaparinux Wiki | 0.35 |
drug383 | Duplex ultrasound and Computed Tomography Angiography Wiki | 0.35 |
drug409 | Enoxaparin Prophylactic Dose Wiki | 0.35 |
drug1413 | thromboprofylaxis protocol Wiki | 0.35 |
drug1414 | thromboprophylaxis with low-molecular-weight heparin or fondaparinux Wiki | 0.35 |
drug485 | Heparin SC Wiki | 0.35 |
drug1402 | standard protocol Wiki | 0.35 |
drug1165 | Tirofiban Injection Wiki | 0.35 |
drug410 | Enoxaparin/Lovenox Intermediate Dose Wiki | 0.35 |
drug38 | Acetylsalicylic acid Wiki | 0.35 |
drug282 | Clopidogrel Wiki | 0.35 |
drug407 | Enoxaparin Wiki | 0.18 |
Name (Synonyms) | Correlation | |
---|---|---|
D013923 | Thromboembolism NIH | 0.79 |
D004617 | Embolism NIH | 0.63 |
D054556 | Venous Thromboembolism NIH | 0.61 |
D016769 | Embolism and Thrombosis NIH | 0.61 |
D013927 | Thrombosis NIH | 0.59 |
D020246 | Venous Thrombosis NIH | 0.47 |
D011655 | Pulmonary Embolism NIH | 0.41 |
D011024 | Pneumonia, Viral NIH | 0.10 |
D016638 | Critical Illness NIH | 0.08 |
D011014 | Pneumonia NIH | 0.05 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
D018352 | Coronavirus Infections NIH | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002625 | Deep venous thrombosis HPO | 0.47 |
HP:0002204 | Pulmonary embolism HPO | 0.41 |
HP:0002090 | Pneumonia HPO | 0.05 |
There are 8 clinical trials
The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.
Description: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
Measure: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism Time: 28 daysDescription: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism
Measure: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism Time: 28 daysThis study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.
Description: Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
Measure: Total Number of Patients with Clinically Relevant Venous or Arterial Thrombotic Events in ICU Time: Discharge from ICU or 30 daysDescription: Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
Measure: Total Number of Patients with In hospital Clinically Relevant Venous or Arterial Thrombotic Events Time: Discharge from hospital or 30 daysDescription: Length of stay measured in days.
Measure: ICU Length of Stay Time: Discharge from ICU or 30 daysDescription: The impact of intermediate-dose anti-coagulation compared with prophylactic anti-coagulation on rates of acute kidney injury and renal recovery in the ICU will be measured with the total number of patients who need of renal replacement therapy in the ICU.
Measure: Total Number of Patients with the Need for Renal Replacement Therapy in the ICU Time: Discharge from hospital or 30 daysDescription: Major bleeding will be assessed by BARC criteria, also explored by International Society on Thrombosis and Haemostasis (ISTH) and Thrombolysis in Myocardial Infarction (TIMI) criteria.
Measure: Total Number of Patients with Major bleeding in the ICU Time: Discharge from hospital or 30 daysDescription: Length of stay measured in days.
Measure: Hospital Length of Stay Time: Discharge from hospital or 30 daysThis 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 treatment
Measure: P/F ratio Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Change in partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: PaO2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: 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 initiationDescription: 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 administrationDescription: 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 initiation
Measure: In-hospital change in intensity of the respiratory support Time: At baseline and 72 and 168 hours after treatment initiationDescription: Difference in partial pressure of carbon dioxide in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: PaCO2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in concentration of bicarbonate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: HCO3- difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in concentration of lactate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: Lactate difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: 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 initiationDescription: 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 initiationDescription: 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 administrationWorldwide 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 death
Measure: Venous thromboembolism Time: 28 daysDescription: Risk of major bleeding defined by the ISTH
Measure: Major bleeding Time: 28 daysDescription: Risk of Major Bleeding and Clinically Relevant Non-Major Bleeding Defined by the ISTH
Measure: Major Bleeding and Clinically Relevant Non-Major Bleeding Time: 28 daysDescription: Risk of Venous Thromboembolism and Major Bleeding
Measure: Net Clinical Benefit Time: 28 days and 2 monthsDescription: Risk of venous thrombosis at other sites: e.g. superficial vein, catheters, hemodialysis access, ECMO, splanchnic, encephalic, upper limb
Measure: Venous Thromboembolism at other sites Time: 28 daysDescription: Risk of arterial thrombosis at any sites
Measure: Arterial Thrombosis Time: 28 daysDescription: Risk of all-cause mortality
Measure: All-Cause Mortality Time: 28 days and 2 monthsDescription: 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 eCRF
Measure: Factors associated with the risk of venous thromboembolism Time: 28 daysSevere 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 daysDescription: Deaths from all causes during the follow-up
Measure: Deaths Time: 7 daysSevere 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 daysDescription: Deaths from all causes during the follow-up
Measure: Deaths Time: 7 daysCoronavirus 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 daysThe aim of this study is to investigate and compare the mortality, the incidence of DVT and the incidence of kidney and liver failure in patients admitted to the ICU before and after the implementation of an intensified thromboprofylaxis protocol on 31st of March 2020. Patients in the before group are admitted at the ICU from 13/3/2020-30/3/2020 and patients in the after group are admitted to the ICU from 31/3 until 20/4/2020.
Description: mortality was assessed in all COVID 19 patients admitted to the ICU
Measure: 2 week mortality Time: 2 weeks after admission at ICUDescription: the incidence of venous thromboembolism was evaluated in all COVID 19 patients admitted to the ICU
Measure: incidence of venous thromboembolism Time: during ICU stay up till 3th of May 2020Description: mortality was assessed in all COVID 19 patients admitted to the ICU
Measure: 1 week mortality Time: 1 week after admission at ICUDescription: mortality was assessed in all COVID 19 patients admitted to the ICU
Measure: 3 week mortality Time: 3 weeks after admission at ICUDescription: mortality was assessed in all COVID 19 patients admitted to the ICU
Measure: 1 month mortality Time: 1 month after admission at ICUDescription: incidence of acute kidney failure in all COVID 19 patients admitted to the ICU
Measure: incidence of kidney failure Time: during ICU stay up till 3th of May 2020Description: incidence of continuous renal replacement therapy (CRRT) in all COVID 19 patients admitted to the ICU
Measure: incidence of continuous renal replacement therapy (CRRT) Time: during ICU stay up till 3th of May 2020Description: evaluation of the lowest P/F ratio in all COVID 19 patients admitted to the ICU
Measure: lowest PaO2/FiO2 (P/F) ratio Time: during ICU stay up till 3th of May 2020Description: evaluation of the highest SOFA score in all COVID 19 patients admitted to the ICU
Measure: highest Sequential Organ Failure Assessment (SOFA) score Time: during ICU stay up till 3th of May 2020Description: evaluation of the length of stay in ICU and hospital of all COVID 19 patients admitted to the ICU
Measure: length of stay Time: during ICU and hospital stay up till 3th of May 2020Description: evaluation of the highest bilirubine level in all COVID 19 patients admitted to the ICU
Measure: highest bilirubin Time: during ICU stay up till 3th of May 2020Description: evaluation of the highest AST level in all COVID 19 patients admitted to the ICU
Measure: highest ( AST Time: during ICU stay up till 3th of May 2020Description: evaluation of the highest ALT level in all COVID 19 patients admitted to the ICU
Measure: highest Aspartaat-Amino-Transferase (ALT) Time: during ICU stay up till 3th of May 2020