Upper Limb Thrombosis Associated With Midline Catheter | NCT03036540

Studies
Upper Limb Thrombosis Associated With Midline Catheter

NCT03036540

Sponsor

University Hospital, Motol

Status

Unknown status

Last Update Posted

Oct 11, 2018Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Venous Thrombosis Deep (Limbs)

Interventions

application in midline catheter

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Jan 26, 2017

First Submission Date that Met QC Criteria

Jan 26, 2017

First Posted Date

Jan 30, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2018

Last Update Posted Date

Oct 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

jiri charvat, prof.MD, PhD, University Hospital, MotolPrincipal Investigator

Lead Sponsor

University Hospital, MotolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
application in midline catheter	Device	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiri Charvat, MD, PhD	Contact	+420603280598		jiri.charvat@lfmotol.cuni.cz
Katerina Lisova, Mgr	Contact	+420224434005		katerina.lisova@fnmotol.cz

Overall Officials

Name	Affiliation	Role
Jiri Charvat, MD,PhD	University Hospital, Motol	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital	Recruiting	Prague		15006	Czechia

IPD Sharing Statement Module

Plan to Share IPD

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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