Central Venous Catheter-related Complications in Patients... | NCT05455866

Studies
Central Venous Catheter-related Complications in Patients Under Anticancer Treatment

NCT05455866

Sponsor

Centre Hospitalier Alpes Leman

Status

Unknown status

Last Update Posted

Jul 13, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Central Venous Catheter Thrombosis
Central Venous Catheter Related Bloodstream Infection
Solid Tumor
Hematologic Malignancy

Interventions

central venous catheter

Countries

Not provided

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2022Estimated

Primary Completion Date

Jan 2023Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Jul 8, 2022

First Submission Date that Met QC Criteria

Jul 8, 2022

First Posted Date

Jul 13, 2022Actual

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

Jul 8, 2022

Last Update Posted Date

Jul 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Oncology and hemotology patients under anticancer treatments are exposed to increased risks of central venous catheter-related complications due to the underlying cancer and its treament.

This prospective observational monocentric french study aims at describing the incidence of such complications, their morbimortality, and analyzing some risk factors in order to contribute to propose some strategies to reduce these complications' rate and consequences

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
central venous catheter	Device	collection and descriptionof central venous catheter-related complications

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence rate and density of central venous catheter-related complications (infections, thromboses, extravasation)		6 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence rate of severe central venous catheter-related complications		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients older than 18 years, with solid cancer or hematological malignancy receiving anticancer treatment in the outpatient medical department of Alpes Leman Hospital and having a central venous catheter been placed between the 11th of July 2022, and the 1st of January 2023.

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

Adult patients at Oncohematology Outpatient Department

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Florence OBERKAMPF	Contact	+33 4 50 82 22 72		foberkampf@ch-alpes-leman.fr

Overall Officials

Name	Affiliation	Role
Florence OBERKAMPF	Centre Hospitalier Alpes Leman	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056824	Upper Extremity Deep Vein Thrombosis
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D020246	Venous Thrombosis
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062905	Central Venous Catheters

Ancestor Terms

ID	Term
D062666	Vascular Access Devices
D057785	Catheters
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided