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Impact of an Intensified Thromboprofylaxis Protocol in COVID-19

Impact of Implementation of an Intensified Thromboprofylaxis Protocol in in Critically Ill ICU Patients With COVID-19: a Longitudinal Controlled Before-after Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04394000
Enrollment
72
Registered
2020-05-19
Start date
2020-05-04
Completion date
2020-05-15
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID19, Thromboembolism

Brief summary

The 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.

Detailed description

Background 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. We have shown in a previous cross sectional study that the prevalence of deep venous thrombosis (DVT) in critically ill ICU patients with COVID-19 treated with a prophylactic dose of low molecular weight heparin (LMWH) is more than 60% (submitted manuscript). Consequently, the risk of VTE complications in this patient group is very high. In the light of these findings, an intensified thromboprofylaxis protocol was applied in critically ill ICU patients with COVID-19 at our ICU units since 31st of March 2020. Aim The 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. Design This is a retrospective, longitudinal, before-after controlled study investigating the mortality, the incidence of DVT and the incidence of kidney and liver failure in COVID-19 patients admitted to the ICU before and after the implementation of an intensified thromboprofylaxis protocol. Outcome measures The primary endpoint of this retrospective study is to investigate the mortality in critically ill ICU patients before and after the implementation of the intensified thromboprofylaxis protocol in our hospital. Secondary endpoints are the incidence of DVTs with the number and locations of these thromboses, the incidence of kidney failure and the incidence of liver failure in COVID-19 patients admitted to the ICU before and after the implementation of the thromboprofylaxis protocol. Additional data collection Additional collected parameters are listed below and are collected as a standard-of-care in our hospital: * Demographics: i.e age, gender, BMI, Apache II score (to predict mortality) * Comorbidities: smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure (AKI), 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, P/F ratio .. * SOFA score (Sequential Organ Failure Assessment) * Radiological findings: pneumonia, ground-glass opacity..

Interventions

OTHERthromboprofylaxis protocol

This individualised protocol contains three cornerstones: an increase in dosage of prophylactic LMWH close to therapeutic doses, introduction of routine venous ultrasonography and daily measurements of plasma anti-factor Xa activity

This protocol contains a routine low dose pharmacological venous thromboembolism (VTE) prophylaxis with LMWH

Sponsors

Jessa Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

\- All adult COVID19+ patients admitted to the ICU from 13th of March until 20th of April 2020.

Exclusion criteria

\- Patients younger than 18 years old.

Design outcomes

Primary

MeasureTime frameDescription
2 week mortality2 weeks after admission at ICUmortality was assessed in all COVID 19 patients admitted to the ICU

Secondary

MeasureTime frameDescription
1 week mortality1 week after admission at ICUmortality was assessed in all COVID 19 patients admitted to the ICU
3 week mortality3 weeks after admission at ICUmortality was assessed in all COVID 19 patients admitted to the ICU
1 month mortality1 month after admission at ICUmortality was assessed in all COVID 19 patients admitted to the ICU
incidence of kidney failureduring ICU stay up till 3th of May 2020incidence of acute kidney failure in all COVID 19 patients admitted to the ICU
incidence of continuous renal replacement therapy (CRRT)during ICU stay up till 3th of May 2020incidence of continuous renal replacement therapy (CRRT) in all COVID 19 patients admitted to the ICU
incidence of venous thromboembolismduring ICU stay up till 3th of May 2020the incidence of venous thromboembolism was evaluated in all COVID 19 patients admitted to the ICU
highest Sequential Organ Failure Assessment (SOFA) scoreduring ICU stay up till 3th of May 2020evaluation of the highest SOFA score in all COVID 19 patients admitted to the ICU
length of stayduring ICU and hospital stay up till 3th of May 2020evaluation of the length of stay in ICU and hospital of all COVID 19 patients admitted to the ICU
highest bilirubinduring ICU stay up till 3th of May 2020evaluation of the highest bilirubine level in all COVID 19 patients admitted to the ICU
highest ( ASTduring ICU stay up till 3th of May 2020evaluation of the highest AST level in all COVID 19 patients admitted to the ICU
highest Aspartaat-Amino-Transferase (ALT)during ICU stay up till 3th of May 2020evaluation of the highest ALT level in all COVID 19 patients admitted to the ICU
lowest PaO2/FiO2 (P/F) ratioduring ICU stay up till 3th of May 2020evaluation of the lowest P/F ratio in all COVID 19 patients admitted to the ICU

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026