Clinical trial NCT03286985: The Prevalence and Incidence of DVT in General ICU
Official title: The Prevalence and Incidence of Deep Venous Thrombosis in General ICU Patients Receiving Enoxaparine Prophylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Venous Thrombosis
Lead sponsor: Masaryk Hospital Krajská zdravotní a.s.
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General ICU patients

Brief summary: Deep venous thrombosis (DVT) represents a major problem in intensive care unit (ICU) patients. Despite the use of recommended pharmacological prophylaxis with low molecular weight heparin (LMWH), the incidence of DVT during ICU stay has been reported between 5 and 15 %. The incidence may vary due to many factors, for example the type of ICU population, the type of protocol of pharmacological prophylaxis and also the type of diagnostic approach. Before formerly planned clinical study targeted to lower DVT incidence by individualizing the dose of LMWH, the investigators decided to evaluate the real DVT incidence in the investigated ICU. The prevalence and incidence will be assessed by ultrasound testing in general ICU patients. on the sample of 200 patients. The investigators hypothesize DVT incidence of 5 %. The compliance to the local DVT prophylaxis protocol will be also evaluated.

Detailed description: 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.

Eligibility criteria: All general ICU patients meeting exclusion and inclusion criteria.

Inclusion criteria:

1. General ICU patient with expected length of stay more than 72 hours

Exclusion Criteria:

1. Inability to perform ultrasound investigation for deep venous thrombosis (for medical or technical reasons)
2. ICU stay shorter than 72 hours

Primary outcomes:
measure: Incidence of deep venous thrombosis
timeFrame: 24 hours from ICU admission to ICU discharge (up to 12 month)
Secondary outcomes:
measure: Prevalence of deep venous thrombosis
timeFrame: From ICU admission to ICU discharge (up to 12 month)
Other outcomes:
Locations:
city: Ústí nad Labem
country: Czechia
facility: Masaryk Hospital
state: Česká Republika
Study officials:
affiliation: Department of Anesthesiology, Perioperative Medicine and Intensive Care, J.E. Purkinje University, Masaryk Hospital in Usti nad Labem, Usti nad Labem, Czech Republic
name: Jan Beneš, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qaseem A, Chou R, Humphrey LL, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Venous thromboembolism prophylaxis in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011 Nov 1;155(9):625-32. doi: 10.7326/0003-4819-155-9-201111010-00011.
citation: Benes J, Skulec R, Jobanek J, Cerny V. Fixed-dose enoxaparin provides efficient DVT prophylaxis in mixed ICU patients despite low anti-Xa levels: A prospective observational cohort study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 May;166(2):204-210. doi: 10.5507/bp.2021.031. Epub 2021 May 27.