The Prevalence and Incidence of DVT in General ICU

NCT03286985 | Completed

• 1 other identifier: 236/60
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prevalence of deep venous thrombosis

  From ICU admission to ICU discharge (up to 12 month)

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General ICU patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Masaryk Hospital Krajská zdravotní a.s.: lead

Study Sites (1)

Masaryk Hospital

Ústí nad Labem, Česká Republika, 40011, Czechia

Location

Related Publications (2)

• 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.

  PMID: 22041951 RESULT

• 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.

  PMID: 34042098 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MUDr. Ing.

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: September 19, 2017
• Study Start: September 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 19, 2020

Record last verified: 2019-03

Locations

CZ (1)