The Prevalence and Incidence of DVT in General ICU

Deep Venous Thrombosis Clinical Trial

— preTIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286985
• Other study ID #: 236/60
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2019
• Source: Masaryk Hospital Krajská zdravotní a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Czechia	Masaryk Hospital	Ústí nad Labem	Ceská Republika

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk Hospital Krajská zdravotní a.s.

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of deep venous thrombosis	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)	24 hours from ICU admission to ICU discharge (up to 12 month)
Secondary	Prevalence of deep venous thrombosis	A number of patients with deep venous thrombosis diagnosed anytime during ICU stay (on admission and during ICU stay)	From ICU admission to ICU discharge (up to 12 month)