Covid 19 Research using Clinical Trials (Home Page)
Report for D020246: Venous Thrombosis NIH
(Synonyms: Venous Thrombosi, Venous Thrombosis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug343 | Heparin Infusion Wiki | 0.58 |
| drug344 | Heparin SC Wiki | 0.58 |
| drug287 | Enoxaparin/Lovenox Intermediate Dose Wiki | 0.58 |
| drug267 | Doppler Echo Wiki | 0.58 |
| drug285 | Enoxaparin Prefilled Syringe [Lovenox] Wiki | 0.58 |
| drug286 | Enoxaparin Prophylactic Dose Wiki | 0.58 |
Correlated MeSH Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013927 | Thrombosis NIH | 0.71 |
| D013923 | Thromboembolism NIH | 0.41 |
| D014777 | Virus Diseases NIH | 0.06 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).
NCT04354155 Infection Viral Thromboses, Venous Drug: Enoxaparin Prefilled Syringe [Lovenox] MeSH:Thrombosis Venous Thrombosis Virus Diseases
HPO:Deep venous thrombosis Venous thrombosis
Primary Outcomes
Description: To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1) fatal bleeding; 2) clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3) retroperitoneal, pulmonary, or central nervous system bleeding; 4) bleeding requiring surgical intervention in an operating suite; 5) bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6) bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.
Measure: Safety of in-hospital thromboprophylaxis Time: Day 30
Secondary Outcomes
Description: The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).
Measure: Median twice-daily enoxaparin dose Time: 4 hours post initial dose
Other Outcomes
Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by the proportion of serial D-dimer levels obtained at standardized time points that are <2 times the upper limit of normal (<2x ULN) values for age.
Measure: Efficacy of in-hospital thromboprophylaxis as measured by the proportion of serial D-dimer levels Time: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized
Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by confirmed HA-VTE.
Measure: Efficacy of in-hospital thromboprophylaxis as measured by confirmed HA-VTE Time: Day 30
Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).
Measure: Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support Time: Day 30
2 Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Primary Outcomes
Description: To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1) fatal bleeding; 2) clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3) retroperitoneal, pulmonary, or central nervous system bleeding; 4) bleeding requiring surgical intervention in an operating suite; 5) bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6) bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.
Measure: Safety of in-hospital thromboprophylaxis Time: Day 30Secondary Outcomes
Description: The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).
Measure: Median twice-daily enoxaparin dose Time: 4 hours post initial doseOther Outcomes
Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by the proportion of serial D-dimer levels obtained at standardized time points that are <2 times the upper limit of normal (<2x ULN) values for age.
Measure: Efficacy of in-hospital thromboprophylaxis as measured by the proportion of serial D-dimer levels Time: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalizedDescription: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by confirmed HA-VTE.
Measure: Efficacy of in-hospital thromboprophylaxis as measured by confirmed HA-VTE Time: Day 30Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).
Measure: Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support Time: Day 30The main objective of the study is to determine the incidence of deep vein thromboses at Doppler echo in patients with SARS-Cov-2 pneumopathy upon their entry into ICU and after 7 days of hospitalization in ICU. This is a monocentric interventional study (RIPH 2).
NCT04363528 Deep Vein Thrombosis Other: Doppler Echo MeSH:Thrombosis Venous Thrombosis
HPO:Deep venous thrombosis Venous thrombosis
Primary Outcomes
Description: Deep vein thrombosis at Doppler echo
Measure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU Time: Day 0
Description: Deep vein thrombosis at Doppler echo
Measure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU Time: Day 7
3 Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19: A Cluster Based Randomized Selection Trial (IMPROVE-COVID)
Primary Outcomes
Description: Deep vein thrombosis at Doppler echo
Measure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU Time: Day 0Description: Deep vein thrombosis at Doppler echo
Measure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU Time: Day 7This 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.
NCT04367831 COVID-19 Venous Thromboses Arterial Thrombosis Drug: Enoxaparin Prophylactic Dose Drug: Heparin Infusion Drug: Heparin SC Drug: Enoxaparin/Lovenox Intermediate Dose MeSH:Thrombosis Thromboembolism Venous Thrombosis
HPO:Deep venous thrombosis Thromboembolism Venous thrombosis
Primary Outcomes
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 days
Secondary Outcomes
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 In hospital Clinically Relevant Venous or Arterial Thrombotic Events Time: Discharge from hospital or 30 days
Description: Length of stay measured in days.
Measure: ICU Length of Stay Time: Discharge from ICU or 30 days
Description: 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 days
Description: 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 days
Description: Length of stay measured in days.
Measure: Hospital Length of Stay Time: Discharge from hospital or 30 days
HPO Nodes
HP:0002625: Deep venous thrombosis
Genes 17
PROC HABP2 F5 SERPINC1 PMM2 F2 AKT1 SERPIND1 SERPINC1 PIEZO1 PROS1 MTHFR PROC THBD F13A1 PLAT F9 SNP 0
HP:0004936: Venous thrombosis
Genes 96
HLA-DPA1 FGA GDF2 MPL TLR4 PTPN22 MET SPINK1 FGG SERPINC1 AKT1 STAT4 CCR1 PROS1 TP53 SAA1 CBS TET2 GNAQ IDH1 FGB JAK2 ACVRL1 IDH2 F5 SERPINC1 CPA1 GNAQ F2 AKT1 SERPIND1 PDGFRA CTRC NOTCH1 JAK2 HBB PROS1 PIEZO1 ERAP1 AGGF1 CDH23 PROC HLA-DPB1 THBD KIF11 F13A1 KLRC4 TET2 IL10 PROS1 UBAC2 PIGM HLA-B IDH2 PROC HABP2 MPL MPL CD55 C4A SMAD4 IL12A-AS1 THPO CALR IL12A CALR IL23R JAK2 HBB CTNNB1 PLAT F9 PRSS1 MEFV TET2 PMM2 IDH1 PTEN CTLA4 PTH1R CASR SH2B3 USP8 MTHFR PROC PRTN3 MPL FAS EPOR CFTR PRKAR1A PDE4D PRSS2 ENG JAK2 PGM1 Protein Mutations 0
SNP 0
Primary Outcomes
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 daysSecondary Outcomes
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 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 days