NCT03036540

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

January 26, 2017

Last Update Submit

October 9, 2018

Conditions

Keywords

upper limb thrombosis, midline catheter

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

The routine insertion of midline catheter for the patients admitted in hospital who needs peripheral venous approach for the period more than 5 days or with the insufficient peripheral veins system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Prague, 15006, Czechia

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Jiri Charvat, MD,PhD

    University Hospital, Motol

    STUDY CHAIR

Central Study Contacts

Jiri Charvat, MD, PhD

CONTACT

Katerina Lisova, Mgr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.MD, PhD

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

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

Locations