The Prevalence and Incidence of DVT in General ICU

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.

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Key information

Conditions

Deep Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Masaryk Hospital

Ústí nad Labem, Česká Republika, 40011, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All general ICU patients meeting exclusion and inclusion criteria.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Masaryk Hospital Krajská zdravotní a.s.

Other

Registry information

Official study title

The Prevalence and Incidence of Deep Venous Thrombosis in General ICU Patients Receiving Enoxaparine Prophylaxis

Acronym: preTIME

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Sep 19, 2017
Registry last updated: Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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