COVID-19-associated Coagulopathy Characterization using Rotational Thromboelastometry in a Prospective, Observational Cohort Study: The HemoCoV Study

Q: What were the main characteristics of patients at ICU admission and during ICU hospitalization?

The main characteristics of patients at ICU admission and during ICU hospitalization included predominantly white and male patients (86.9% and 73.8%, respectively) with a median age of 64 years (IQR 55 -74). Arterial hypertension was the most prevalent comorbidity (63.4%). Previous thrombosis was documented in six patients. Blood counts, biochemical parameters, inflammatory markers, coagulation parameters, and SOFA score showed significant differences between admission and discharge. Thromboelastometric findings indicated hypercoagulability and hypofibrinolysis, with greater severity in non-survivors. Most patients received prophylactic and intermediate doses of LMWH, with no differences in hypercoagulability and hypofibrinolysis profiles between patients receiving different heparin doses.

Q: What are the coagulation abnormalities observed in COVID-19 patients during 30 days of ICU hospitalization?

HemoCoV study evaluated COVID-19-associated coagulopathy (CAC) and its implications in the clinical course of SARS-CoV-2 infection along 30 days of ICU hospitalization. The study found significant coagulation abnormalities expressed by hypercoagulability and hypofibrinolysis, since ICU admission (initial phases of disease) and persisting throughout the clinical course. Both changes were more pronounced in patients with higher disease severity and in non-survivors. Hypofibrinolysis was more prevalent and severe in non-survivors. Thromboelastometry parameters may be useful to distinguish coagulation patterns between patients with non-severe and severe COVID-19. The higher burden of fibrinogen and other coagulation factors (FVIII, vWF) along the clinical course of COVID-19 was observed in the study. Hypercoagulability was proposed as a cut-off for MCF-FIBTEM over 27mm to differentiate between severe and non-severe forms of COVID-19 disease. Decreased fibrinolysis suggests a prothrombotic condition and compromises vascular permeability. D-dimer levels did not differ significantly between time point analyses, but fibrinogen levels significantly differed from ICU admission to discharge. Severe lymphopenia was identified in the study, with a statistically significant difference in lymphocyte count between ICU admission and discharge. The study highlights the complex interactions of the coagulation system and the need for a careful assessment of fibrinogen for stratifying CAC. The longitudinal temporal characterization of coagulation abnormalities suggests that pathophysiological mechanisms involved in COVID-19 may be related to a hyperthrombotic profile along with hypofibrinolysis, which could be useful in clinical practice for defining distinctive therapeutic interventions and stratification of the patient's individual risk in subsequent studies.

Question

1. What factors contribute to COVID-19 severity?

2. What were the inclusion criteria for patient enrollment in the COVID-19 study?

3. What are the inclusion criteria for patients in the ICU study?

4. What is the definition of a clinically significant hemorrhagic event?

Accepted Answer

Factors contributing to COVID-19 severity include immunological activation, coagulation dysregulation, thrombus inflammation, thrombosis, endothelitis, hyperinflammation, T cell deficiencies, and coagulation abnormalities. These factors lead to hypercoagulability, systemic fibrinolysis shutdown, and life-threatening organ dysfunction. Lymphocyte count is also a potential marker for severe COVID-19. A study involving critically ill patients with SARS-CoV-2 infection and severe respiratory failure aimed to identify factors related to disease severity and contribute to a better understanding of COVID-19 pathophysiology.

Accepted Answer

The inclusion criteria for patient enrollment in the COVID-19 study involved assessing patients admitted to the ICU with a diagnosis of COVID-19-related acute respiratory failure (ARF). Written informed consent was obtained from all patients. The diagnosis of SARS-CoV-2 infection was confirmed by two positive polymerase chain reaction tests, following national health authority recommendations. Respiratory failure was defined as oxygen requirement administered through high-flow nasal cannula, non-invasive ventilation, or invasive mechanical ventilation (IMV), in line with the World Health Organization (WHO) clinical progression scale definition of hospitalized severe disease. The study evaluated consecutive adult patients admitted between August 20, 2020, and January 15, 2021.

Accepted Answer

The inclusion criteria for patients in the ICU study are individuals aged 18 years or older with confirmed SARS-CoV-2 infection, admitted to the ICU with moderate to severe hypoxemia (PaO2/FiO2 ratio below 200), regardless of ventilatory status. This ensures that the study focuses on a specific patient population with a particular medical condition, allowing for more accurate and relevant research findings. By including patients with confirmed SARS-CoV-2 infection and moderate to severe hypoxemia, the study aims to investigate the effects of the virus on patients with compromised respiratory function. This specificity helps in targeting the research towards understanding the impact of SARS-CoV-2 on patients with severe respiratory distress, which is crucial for developing effective treatment strategies and improving patient outcomes.

Accepted Answer

A clinically significant hemorrhagic event is defined as grade 2 or higher of the WHO bleeding score. This score is used to assess the severity of bleeding in patients. The WHO bleeding score takes into account various factors such as the amount of blood loss, the need for blood transfusions, and the impact of bleeding on the patient's overall condition. By using this scoring system, healthcare professionals can better understand the severity of a hemorrhagic event and make informed decisions about the appropriate treatment and management strategies for the patient.

Accepted Answer

The key patient baseline characteristics evaluated in the clinical data section include blood group, relevant comorbidities, and previous antithrombotic therapy. Additionally, risk and prognostic scores such as simplified acute physiology score II (SAPS II), sequential organ failure assessment (SOFA), sepsis-induced coagulopathy score (SIC) 30, and disseminated intravascular coagulopathy score (DIC) are also assessed. These factors provide valuable insights into the patient's condition and help in determining the appropriate treatment approach.

Accepted Answer

Rotational thromboelastometry (ROTEM) evaluates the global coagulation process on whole blood. It assesses clot initiation, clot strength or amplitude, and clot stability. The system measures clot initiation (CT), clot strength or amplitude (A5, A10, fibrinogen and platelet contribution), and clot stability (fibrinolysis: LI30, LI60, ML). Additionally, it includes four assays for extrinsic (EXTEM) and intrinsic (INTEM) clot activation, fibrinogen contribution to clot formation (FIBTEM), and heparin presence (HEPTEM). The ROTEM (r) Delta device is used for these evaluations, following the manufacturer's instructions.

Accepted Answer

For continuous variables, the Mann-Whitney U test was used, while for categorical variables, the Kruskal-Wallis test was applied. Fisher's exact test was used when applicable. These tests were performed using the software R Studio version 4.1.2. All results with a p-value < 0.05 were considered significant. This approach allowed for the comparison of baseline clinical characteristics, clinical and laboratory data, and patient characteristics between survivors and non-survivors in the study.

Accepted Answer

The main characteristics of patients at ICU admission and during ICU hospitalization included predominantly white and male patients (86.9% and 73.8%, respectively) with a median age of 64 years (IQR 55 -74). Arterial hypertension was the most prevalent comorbidity (63.4%). Previous thrombosis was documented in six patients. Blood counts, biochemical parameters, inflammatory markers, coagulation parameters, and SOFA score showed significant differences between admission and discharge. Thromboelastometric findings indicated hypercoagulability and hypofibrinolysis, with greater severity in non-survivors. Most patients received prophylactic and intermediate doses of LMWH, with no differences in hypercoagulability and hypofibrinolysis profiles between patients receiving different heparin doses.

Accepted Answer

HemoCoV study evaluated COVID-19-associated coagulopathy (CAC) and its implications in the clinical course of SARS-CoV-2 infection along 30 days of ICU hospitalization. The study found significant coagulation abnormalities expressed by hypercoagulability and hypofibrinolysis, since ICU admission (initial phases of disease) and persisting throughout the clinical course. Both changes were more pronounced in patients with higher disease severity and in non-survivors. Hypofibrinolysis was more prevalent and severe in non-survivors. Thromboelastometry parameters may be useful to distinguish coagulation patterns between patients with non-severe and severe COVID-19. The higher burden of fibrinogen and other coagulation factors (FVIII, vWF) along the clinical course of COVID-19 was observed in the study. Hypercoagulability was proposed as a cut-off for MCF-FIBTEM over 27mm to differentiate between severe and non-severe forms of COVID-19 disease. Decreased fibrinolysis suggests a prothrombotic condition and compromises vascular permeability. D-dimer levels did not differ significantly between time point analyses, but fibrinogen levels significantly differed from ICU admission to discharge. Severe lymphopenia was identified in the study, with a statistically significant difference in lymphocyte count between ICU admission and discharge. The study highlights the complex interactions of the coagulation system and the need for a careful assessment of fibrinogen for stratifying CAC. The longitudinal temporal characterization of coagulation abnormalities suggests that pathophysiological mechanisms involved in COVID-19 may be related to a hyperthrombotic profile along with hypofibrinolysis, which could be useful in clinical practice for defining distinctive therapeutic interventions and stratification of the patient's individual risk in subsequent studies.

COVID-19-associated Coagulopathy Characterization using Rotational Thromboelastometry in a Prospective, Observational Cohort Study: The HemoCoV Study

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Most frequently asked questions

1. What factors contribute to COVID-19 severity?

2. What were the inclusion criteria for patient enrollment in the COVID-19 study?

3. What are the inclusion criteria for patients in the ICU study?

4. What is the definition of a clinically significant hemorrhagic event?

5. What are the key patient baseline characteristics evaluated in the clinical data section?

6. What does Rotational thromboelastometry (ROTEM) evaluate?

7. What statistical tests were used for comparing continuous and categorical variables?

8. What were the main characteristics of patients at ICU admission and during ICU hospitalization?

9. What are the coagulation abnormalities observed in COVID-19 patients during 30 days of ICU hospitalization?

Citations

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References

Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study.

The Strengthening the Reporting of Observational Studies in Epidemiology [STROBE] statement: guidelines for reporting observational studies

Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China

Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia.

COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-up

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