The Prevalence and Incidence of DVT in General ICU (preTIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03286985
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):
Jan Benes, Masaryk Hospital Krajská zdravotní a.s.

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.

Condition or disease
Deep Venous Thrombosis

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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General ICU patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03286985

Contact: Jan Beneš, MD +420 731 166 542
Contact: Roman Škulec, MD, PhD +420 777 577 497

Masaryk Hospital Recruiting
Ústí nad Labem, Česká Republika, Czechia, 40011
Contact: Jan Beneš, MD    477112204   
Sponsors and Collaborators
Masaryk Hospital Krajská zdravotní a.s.
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

Publications of Results:
Responsible Party: Jan Benes, MUDr. Ing., Masaryk Hospital Krajská zdravotní a.s. Identifier: NCT03286985     History of Changes
Other Study ID Numbers: 236/60
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases