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| Name | Class |
|---|---|
| Universitat Autonoma de Barcelona | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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 |
|
| control group | No Intervention | This group only undergo the first ultrasound assessment to discard previous thrombosis not detected during hospitalisation or ambulatory |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venous ultrasound of lower extremity | Diagnostic Test | Patients are explored for deep vein thrombosis in femoral-popliteal and distal veins of the legs with ultrasound compression and doppler flow evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Patients that die in ICU during follow up | 21 days |
| ICU Stay | Number of days staying in that unit during follow up | 21 days |
| Symptomatic deep venous thrombosis | presence of confirmed deep vein thrombosis and presence of symptoms | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome | a composite outcome with poor outcome factors (symptomatic DVT, bleeding, ICU stay >21 days) | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergi Bellmunt Montoya | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9428249 | Background | Wells PS, Anderson DR, Bormanis J, Guy F, Mitchell M, Gray L, Clement C, Robinson KS, Lewandowski B. Value of assessment of pretest probability of deep-vein thrombosis in clinical management. Lancet. 1997 Dec 20-27;350(9094):1795-8. doi: 10.1016/S0140-6736(97)08140-3. | |
| 33586113 | Background | Jenner WJ, Kanji R, Mirsadraee S, Gue YX, Price S, Prasad S, Gorog DA. Thrombotic complications in 2928 patients with COVID-19 treated in intensive care: a systematic review. J Thromb Thrombolysis. 2021 Apr;51(3):595-607. doi: 10.1007/s11239-021-02394-7. Epub 2021 Feb 14. |
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The selected patients undergo an ultrasound of lower extremity to discard previous thrombosis episodes. Then they are randomized to an intervention group (serial screening of deep venous thrombosis in lower extremity 2 times per week) or control group (no other exploration or interventions are made).
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| 33585578 | Background | Mohamed MFH, Al-Shokri SD, Shunnar KM, Mohamed SF, Najim MS, Ibrahim SI, Elewa H, Abdalla LO, El-Bardissy A, Elshafei MN, Abubeker IY, Danjuma M, Dousa KM, Yassin MA. Prevalence of Venous Thromboembolism in Critically Ill COVID-19 Patients: Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2021 Jan 8;7:598846. doi: 10.3389/fcvm.2020.598846. eCollection 2020. |
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| 39838947 | Derived | Marrero Eligio De La Puente CE, Flota Ruiz D, Besalduch LS, Capo XF, Sala DG, Ibars CP, Mindiolaza IB, Chiscano Camon LS, Sanmartin AR, Ruiz-Rodriguez JC, Ferrer R, Montoya SB. Systematic Ultrasound Screening for Lower Extremity Deep Vein Thrombosis in ICU Patients with Severe COVID-19: A Randomized Clinical Trial. J Intensive Care Med. 2025 Jul;40(7):739-748. doi: 10.1177/08850666251313774. Epub 2025 Jan 22. |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D000086382 | COVID-19 |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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