Impact of an Intensified Thromboprofylaxis Protocol in COVID-19

COVID19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394000
• Other study ID #: Jessa_20.48
• Status: Completed
• Start date: May 4, 2020
• Est. completion date: May 15, 2020

Study information

• Verified date: May 2020
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID19
• Thromboembolism

Intervention

Other:
• thromboprofylaxis 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
• standard protocol
This protocol contains a routine low dose pharmacological venous thromboembolism (VTE) prophylaxis with LMWH

Locations

Country	Name	City	State
Belgium	Jessa hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 week mortality	mortality was assessed in all COVID 19 patients admitted to the ICU	2 weeks after admission at ICU
Secondary	incidence of venous thromboembolism	the incidence of venous thromboembolism was evaluated in all COVID 19 patients admitted to the ICU	during ICU stay up till 3th of May 2020
Secondary	1 week mortality	mortality was assessed in all COVID 19 patients admitted to the ICU	1 week after admission at ICU
Secondary	3 week mortality	mortality was assessed in all COVID 19 patients admitted to the ICU	3 weeks after admission at ICU
Secondary	1 month mortality	mortality was assessed in all COVID 19 patients admitted to the ICU	1 month after admission at ICU
Secondary	incidence of kidney failure	incidence of acute kidney failure in all COVID 19 patients admitted to the ICU	during ICU stay up till 3th of May 2020
Secondary	incidence of continuous renal replacement therapy (CRRT)	incidence of continuous renal replacement therapy (CRRT) in all COVID 19 patients admitted to the ICU	during ICU stay up till 3th of May 2020
Secondary	lowest PaO2/FiO2 (P/F) ratio	evaluation of the lowest P/F ratio in all COVID 19 patients admitted to the ICU	during ICU stay up till 3th of May 2020
Secondary	highest Sequential Organ Failure Assessment (SOFA) score	evaluation of the highest SOFA score in all COVID 19 patients admitted to the ICU	during ICU stay up till 3th of May 2020
Secondary	length of stay	evaluation of the length of stay in ICU and hospital of all COVID 19 patients admitted to the ICU	during ICU and hospital stay up till 3th of May 2020
Secondary	highest bilirubin	evaluation of the highest bilirubine level in all COVID 19 patients admitted to the ICU	during ICU stay up till 3th of May 2020
Secondary	highest ( AST	evaluation of the highest AST level in all COVID 19 patients admitted to the ICU	during ICU stay up till 3th of May 2020
Secondary	highest Aspartaat-Amino-Transferase (ALT)	evaluation of the highest ALT level in all COVID 19 patients admitted to the ICU	during ICU stay up till 3th of May 2020