Evaluation of Serial Ultrasound Screening in ICU COVID-19 Patients

April 8, 2024 updated by: Hospital Universitari Vall d'Hebron Research Institute

Systematic Ultrasound Screening for Lower Extremity Deep Vein Thrombosis in ICU Patients With Severe COVID-19: a Randomized Clinical Trial.

This clinical trial is designed to evaluate if the periodic screening for deep venous thrombosis by ultrasound of lower extremity in patients with intensive care unit (ICU) patients with COVID 19 impacts on mortality, ICU stay and total length of stay in the hospital, along with other outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: COVID-19 has a high incidence of venous thromboembolic disease (VTE), especially pulmonary thromboembolism (PE) and deep vein thrombosis (DVT), with an even higher incidence in patients admitted to the intensive care unit (ICU). The presentation of these events is related to an increase in mortality and the mean stay in the ICU. The impact of systematic screening for asymptomatic lower extremity DVT in these patients has not been studied, so we propose to carry out a clinical trial to assess its impact in these patients.

Hypothesis: Serial DVT screening in patients admitted to the ICU for COVID-19 does not improve survival, mean stay, or the incidence of symptomatic VTE.

Objective: To study whether DVT screening in these patients has an impact on the incidence of symptomatic VTE, mortality and average stay in the ICU.

Methods: Non-blind randomized clinical trial on all patients aged 18 years or older admitted to the ICU for COVID-19 with less than 72 hours elapsed since their admission to the unit. Patients with DVT or PE will be excluded at the time of recruitment (all patients will be ruled out by routine ultrasound and computed tomography angiography (CT Angiography)); Pregnant patients, patients with a previous diagnosis of DVT or PE, and patients undergoing extracorporeal membrane oxygenation (ECMO) will also be excluded. Patients will be randomized into two arms at the time of inclusion: the screened group (Group 1) and the non-screened group (Group 2). Group 1: patients who will be treated according to the usual ICU protocol and, additionally, will undergo serial ultrasounds of the lower extremities twice a week (Monday and Thursday). Group 2: they will be treated according to the usual ICU protocol and no screening examinations will be performed. Patients will be followed until discharge from the ICU or death and up to a maximum of 3 weeks. The incidence of symptomatic VTE will be assessed, as well as all-cause mortality and days of stay in the ICU. Clinical and laboratory variables will be collected from each patient for subsequent statistical analysis.

Relevance: The thrombotic complications of COVID-19 are well described, as well as their high incidence in critically ill patients. This work aims to clarify the current doubts about the need for systematic DVT screening in these patients. If our hypothesis is verified, a limited resource such as ultrasound of the lower limbs could be saved, as well as the use of the necessary protection materials and, most importantly, avoid unnecessary exposure of health personnel with the consequent risk that it represents for other professionals and patients.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • COVID 19 patients in their first 72 hours of entering ICU

Exclusion Criteria:

  • Pregnant patients
  • Not COVID 19 confirmed patients by RCP
  • Patients that are in Extracorporeal membrane oxygenation
  • Patients with previous thrombotic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Selected patients undergo lower extremity ultrasound for diagnosis of deep vein thrombosis 2 times per week (Mondays and Thursdays) in a period of 3 weeks (21 days) of follow up
Diagnostic test: venous ultrasound of lower extremity
Patients are explored for deep vein thrombosis in femoral-popliteal and distal veins of the legs with ultrasound compression and doppler flow evaluation
No Intervention: control group
This group only undergo the first ultrasound assessment to discard previous thrombosis not detected during hospitalisation or ambulatory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 21 days
Patients that die in ICU during follow up
21 days
ICU Stay
Time Frame: 21 days
Number of days staying in that unit during follow up
21 days
Symptomatic deep venous thrombosis
Time Frame: 21 days
presence of confirmed deep vein thrombosis and presence of symptoms
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite outcome
Time Frame: 21 days
a composite outcome with poor outcome factors (symptomatic DVT, bleeding, ICU stay >21 days)
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Universitat Autonoma de Barcelona

Investigators

  • Principal Investigator: Sergi Bellmunt Montoya, Hospital Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

August 15, 2021

Study Completion (Actual)

December 13, 2021

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/R(AG)176/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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