The Prevalence and Incidence of DVT in General ICU (preTIME)
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|ClinicalTrials.gov Identifier: NCT03286985|
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
|Condition or disease|
|Deep Venous Thrombosis|
Type of the study: Observational prospective cohort study. Hypothesis: Despite appropriate prophylaxis of deep venous thrombosis in general ICU patients in accordance with the current guidelines, the incidence of deep venous thrombosis is 5 - 10%.
Sample size: 200 consecutive general ICU patients. Inclusion and exclusion criteria: defined in the Eligibility section. Protocol description: All patients admitted to ICU with expected period of the stay longer than 72 hours will be evaluated for the presence of deep venous thrombosis by ultrasound testing during the first 48 hours of ICU stay. Thereafter, each participant will be examined by ultrasound testing twice a week until the discharge from ICU. All patients will receive deep venous thrombosis prophylaxis following the current guidelines. All patients with positive finding of deep venous thrombosis will be managed in accordance with the current guidelines.
Ultrasound examination for deep venous thrombosis: Ultrasound compression test at the following locations: common femoral vein at the groin, deep femoral vein, popliteal vein, both extremities.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||The Prevalence and Incidence of Deep Venous Thrombosis in General ICU Patients Receiving Enoxaparine Prophylaxis|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||May 2018|
General ICU patients
No intervention is associated with inclusion to the study (observational study). Included will be all patients admitted to general ICU with ICU stay >72 hours, having deep venous thrombosis prophylaxis appropriate to clinical setting and following the recent guidelines. All study participants will undergo repeated noninvasive ultrasound testing for deep venous thrombosis, which is normal part of the routine care in our ICU.
- Incidence of deep venous thrombosis [ Time Frame: 24 hours from ICU admission to ICU discharge (up to 12 month) ]Number of patients with new onset deep venous thrombosis diagnosed during ICU stay (ie deep venoous thrombosis developed after the first 24 hours of ICU stay)
- Prevalence of deep venous thrombosis [ Time Frame: From ICU admission to ICU discharge (up to 12 month) ]A number of patients with deep venous thrombosis diagnosed anytime during ICU stay (on admission and during ICU stay)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286985
|Contact: Jan Beneš, MD||+420 731 166 firstname.lastname@example.org|
|Contact: Roman Škulec, MD, PhD||+420 777 577 email@example.com|
|Ústí nad Labem, Česká Republika, Czechia, 40011|
|Contact: Jan Beneš, MD 477112204 firstname.lastname@example.org|
|Principal Investigator:||Jan Beneš, MD||Department of Anesthesiology, Perioperative Medicine and Intensive Care, J.E. Purkinje University, Masaryk Hospital in Usti nad Labem, Usti nad Labem, Czech Republic|