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COVID-19 and Deep Venous Thrombosis

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ClinicalTrials.gov Identifier: NCT04338932
Recruitment Status : Completed
First Posted : April 8, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Stessel Björn, Jessa Hospital

Brief Summary:
The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).

Condition or disease
COVID-19 Deep Vein Thrombosis (DVT)/Thrombophlebitis

Detailed Description:

Patients admitted to the Intensive Care Unit (ICU) are known to be at risk for thrombo-embolic events. Virchow's triad describes the major risk factors in three categories: venous stasis, vessel injury and activation of blood coagulation. A prolonged mechanical ventilation together with the hemodynamic effects of this ventilation with a high positive and expiratory pressure (PEEP), the presence of central venous catheters, the immobilization of these patients and the presence of obesity or other comorbidities can attribute to the occurrence of a deep venous thrombosis (DVT) in patients admitted at ICU. The incidence of DVT during ICU stay has been reported between 5 and 15%.

On the 13th of March, the first COVID-19 patient was admitted at the ICU at the Jessa Hospital. Within a few days, the admissions at our COVID-19 unit grew exponential. In these difficult time, research concerning COVID-19 has been performed indicating the COVID-19 virus induces a hyper-inflammatory state. It has been suggested that systemic inflammation induces endothelial injury. This will activate the coagulation cascade and impair fibrinolysis with disruption of endothelial barrier, and loss of physiologic antithrombotic factors which may elevated the risk for DVTs significantly. Up to now, there is still no causal treatment for COVID-19. The current management of COVID-19 is mainly supportive i.e. a prolonged inflammatory status and a prolonged risk for VTE.

During the placement of a dialysis catheter in the femoral vein of one of the patients admitted in the ICU for COVID-19 at our hospital, a large deep vein thrombosis (DVT) proximal in both common femoral veins was noticed in a patient. Since there were no clinical signs of DVT present in this patient, every patient at the ICU unit at that moment was screened on the presence of DVTs. We found one or several deep vein thromboses in 8 out of 12 patients at 1 ICU unit. Since this was a unusual high incidence, we want to further investigate this prevalence and evaluate possible causes of these DVTs.

The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).

The endpoint of this cross-sectional study is to investigate the prevalence and identify possible risk factors of the occurrence of a DVT in these patients at the ICU.

These parameters are listed below and included parameters/values collected as a standard-of-care in our hospital:

  • Demographics: i.e age, gender
  • Comorbidities: smoking, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure, liver failure, gastrointestinal disease, neurological conditions, mental state, other
  • Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc…
  • Laboratory results of all standard parameters measured
  • Treatment: antiviral agents, antibiotics, etc…
  • Complications: shock, heart failure, sepsis, stroke, etc…
  • Ventilation: method, PEEP, FiO2, ..
  • Radiological findings: pneumonia, ground-glass opacity..

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: COVID-19 and Deep Venous Thrombosis: a Cross-sectional Study
Actual Study Start Date : April 17, 2020
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 15, 2020





Primary Outcome Measures :
  1. the prevalence of a DVT in patients at the ICU. [ Time Frame: 1 day at ICU ]
    to investigate the prevalence of a DVT in patients at the ICU.


Secondary Outcome Measures :
  1. Oxygen partial pressure and Carbon dioxide partial pressure levels in the blood [ Time Frame: 1 day at ICU ]
    evaluate pO2 and pCO2 (mmHg) in patients with and without a DVT

  2. Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels in the blood [ Time Frame: 1 day at ICU ]
    evaluate Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels (mmol/l) in patients with and without a DVT

  3. glucose, haemoglobin, ureum, creatinine, total bilirubin levels in the blood [ Time Frame: 1 day at ICU ]
    evaluate glucose, haemoglobin, ureum, creatinine, total bilirubin levels (mg/dl) in patients with and without a DVT

  4. oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood [ Time Frame: 1 day at ICU ]
    evaluate oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood (%) in patients with and without a DVT

  5. white blood cells, red blood cells and platelets in the blood [ Time Frame: 1 day at ICU ]
    evaluate white blood cells (x 10*9/L), red blood cells (x 10*12/L) and platelets levels (x 109/L) in the blood in patients with and without a DVT

  6. PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L)in the blood [ Time Frame: 1 day at ICU ]
    evaluate PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L) in the blood in patients with and without a DVT

  7. prevalence of co-morbidities [ Time Frame: 1 day at ICU ]
    revalence of co morbidities such as Cardiovascular disease, n (%) Hypertension, n (%) Diabetes, n (%) Respiratory disease, n (%) Malignancy, n (%) Chronic renal disease, n (%) Chronic liver disease, n (%) Chronic bowel disease, n (%) Chronic nerve disease, n (%) Cerebrovascular disease, n (%) HIV/AIDS, n (%) Haematological disease, n (%) Obesity, n (%) Rheumatological disease, n (%) Dementia, n (%) in patients with and without a DVT admitted at the ICU in 1 day

  8. prevalence of vital signs at icu admission [ Time Frame: at ICU admission ]
    prevalence of vital signs such Temperature (°C) Breathing rate (#/min) Systolic blood pressure (mmHg) Mean arterial blood pressure (mmHg) Heart rate (#/min) Glasgow Coma Scale in patients with and without a DVT

  9. prevalence of complications during icu stay [ Time Frame: from ICU admission to cross sectional moment (29/3/2020) ]
    prevalance of complications such as ARDS Acute kidney failure Acute heart failure Septic shock Secondary infection Seizure Stroke Hyperglaecemia Hypoglaecemia during ICU stay in patients with and without DVT

  10. evaluation of treatment [ Time Frame: from ICU admission to cross sectional moment (29/3/2020) ]
    evaluation of treatment such as Antiviral treatment Antibiotic treatment Antifungal treatment Corticosteroid treatment CRRT IVIg treatment Plaquenil treatment during ICU stay in patients with and without DVT

  11. evaluation of the oxygen therapy [ Time Frame: from ICU admission to cross sectional moment (29/3/2020) ]
    evaluation of the oxygen therapy such as Invasive mechanical ventilation FiO2 (mmHg) PEEP Length of ventilationA ECMO Invasive mechanical ventilation + ECMO Vasopressor/inotropic support Neuromuscular blocking agents Prone ventilation in patients with and without DVT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
Criteria

Inclusion Criteria:

  • 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338932


Locations
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Belgium
Jessa hospital
Hasselt, Belgium, 3500
Sponsors and Collaborators
Jessa Hospital
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Responsible Party: Stessel Björn, Dr, Jessa Hospital
ClinicalTrials.gov Identifier: NCT04338932    
Other Study ID Numbers: JessaH_COVID19_DVT
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Thrombophlebitis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Vasculitis