Upper Limb Thrombosis Associated With Midline Catheter

Symptomatic and Asymptomatic Thrombosis in Midline Catheter

The patients admitted in hospital who had midline catheter inserted in upper limb are followed-up for the presence of complications related to catheter introductions. The symptoms and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography examination. In the selected group of asymptomatic patients sonography examination is done 8 to 10 days after cathether insertion in order to detect the incidence of the asymptomatic thrombosis

Study Overview

• Status: Unknown
• Conditions: Venous Thrombosis Deep (Limbs)
• Intervention / Treatment: Device: application in midline catheter

Detailed Description

The patients admitted in hospital who had midline catheter inserted in upper limb are followed-up for the presence of complications related to catheter introductions. The symptoms and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography examination. The age, gender, principal diagnosis, the vein were midline catheter is inserted and number of vein punctures for catheter insertion are recorded. Afterward the patients are treated in the ward and the possible complications are recorded. The main concern is about the incidence of upper limb thrombosis. All the complications are recorded as well as date when they has appeared. The statistical analysis is done in order to evaluate the incidence of upper limb symptomatic thrombosis, the duration since insertion to thrombosis manifestation ańad its associations with age, gender, principal diagnosis, selected vein, its size and number of punctures is analysed.

In the selected group of the asymptomatic patients 8 to 10 days after midline insertion upper limb sonography is done in order to detect the presence of the asymptomatic upper limb thrombosis and the same type of analysis as for symptomatic thrombosis is undertaken.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Jiri Charvat, MD, PhD; Phone Number: +420603280598; Email: jiri.charvat@lfmotol.cuni.cz
• Study Contact Backup: Name: katerina lisova, Mgr; Phone Number: +420224434005; Email: katerina.lisova@fnmotol.cz

Study Locations

• Czechia
  • Praga, Czechia, 15006
    • Recruiting
    • University Hospital
    • Contact: katerina lisova, Mgr; Phone Number: +420224434005; Email: katerina.lisova@fnmotol.cz
    • Contact: Jiri Charvat, MD,PhD; Phone Number: +420603280598; Email: jiri.charvat@lfmotol.cuni.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients admitted to University Hospital suffering from disease when venous access is required for period longer than 5 days or with insufficient peripheral venous access

Description

Inclusion Criteria:

• The patients admitted to University Hospital suffering from disease when venous access is required for period longer than 5 days or with insufficient peripheral venous access

Exclusion Criteria:

The patients who need another type of venous access, e.g. central venous access

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The symptomatic and asymptomatic upper limb thrombosis in the patients with midline catheter	The detection of the incidence of upper limb thrombosis and definition of the associated factors	admitted patients in hospital during one year with midline catheter insertion

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Investigators: Study Chair: Jiri Charvat, MD,PhD, University Hospital, Motol

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: upper limb thrombosis, midline catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: UHMotol6022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The patients with the inseertion of midline catheter during admission in hospital are followed-up for the possible complications including symptoms and signs of symptomatic and asymptomatic upper limb thrombosis using sonography examinations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No