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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03286985
Other study ID # 236/60
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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