Risk Prediction of Venous Thromboembolism in Critically Ill

NCT03773939 | Unknown

• 1 other identifier: 201800246 - 2
• Study Type: observational
• Target: 5,400
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Venous thromboembolism (VTE), including both deep vein thrombosis and pulmonary embolism, is a frequent cause of morbidity and mortality. The population of critically ill patients is a heterogeneous group of patients with an overall high average risk of developing VTE. No prognostic model has been developed for estimation of this risk specifically in critically ill patients. The aim is to construct and validate a risk assessment model for predicting the risk of in-hospital VTE in critically ill patients. Methods: In the first phase of the study we will create a prognostic model based on a derivation cohort of critically ill patients who were acutely admitted to the intensive care unit. A point-based clinical prediction model will be created using backward stepwise regression analysis from a selection of predefined candidate predictors. Model performance, discrimination and calibration will be evaluated, and the model will be internally validated by bootstrapping. In the second phase of the study, external validation will be performed in an independent cohort, and additionally model performance will be compared with performance of existing VTE risk prediction models derived from, and applied to, general medical patients. Dissemination: This protocol will be published online. The results will be reported according to the Transparent Reporting of multivariate prediction models for Individual Prognosis Or Diagnosis (TRIPOD) statement, and submitted to a peer-reviewed journal for publication.

Conditions

Venous Thrombosis; Critical Illness

Outcome Measures

Primary Outcomes (1)

• In-hospital VTE

  VTE will be defined as any objectively proven event occurring during initial hospital admission. No screening protocol will be used. DVT will include acute thrombosis of lower-extremity veins (iliac, femoral or popliteal), confirmed by compression ultrasonography, venography, CT, MRI, or autopsy. Pulmonary embolism will be defined as acute thrombosis within the pulmonary vasculature as shown by ventilation-perfusion scan, CT angiography, or autopsy. Upper extremity DVT or venous thrombosis in another site will be excluded from the model but included in a sensitivity analysis. All VTE events will be adjudicated by the study coordinator before the development of the prediction model.

  Initial hospital admission

Study Arms (2)

Derivation cohort

Prospective cohort study based on the 'Simple Intensive Care Studies' (SICS) registry (NCT02912624, NCT03577405, and NCT03553069)

External validation cohort

We will create a multicenter cohort based on prospectively collected data derived from the Dutch National Intensive Care Evaluation (NICE) registry

Eligibility Criteria

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

Study Population

Critically ill patients

You may qualify if:

• Emergency admission
• Expected stay \> 24 hours

You may not qualify if:

• Age \< 18 years
• Planned admission either after surgery or for other reasons
• Unable to provide informed consent

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

Related Publications (1)

• Eck RJ, Hulshof L, Wiersema R, Thio CHL, Hiemstra B, van den Oever NCG, Gans ROB, van der Horst ICC, Meijer K, Keus F. Incidence, prognostic factors, and outcomes of venous thromboembolism in critically ill patients: data from two prospective cohort studies. Crit Care. 2021 Jan 12;25(1):27. doi: 10.1186/s13054-021-03457-0.

  PMID: 33436012 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Critical Illness

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

I.C.C. van der Horst, Associate professor

CONTACT

i.c.c.van.der.horst@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 12, 2018
• Study Start: March 27, 2015
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 15, 2019

Record last verified: 2018-12

Locations

NL (1)