Complications and Risk Factors Related With Central Venou... | NCT01661218

Studies
Complications and Risk Factors Related With Central Venous Catheters in Cancer Patients

NCT01661218

Sponsor

Beijing Huanxing Cancer Hospital

Status

Completed

Last Update Posted

Sep 3, 2020Actual

Enrollment

3,500Actual

Phase

Not provided

Conditions

Thrombosis
Infections

Interventions

Not provided

Countries

China

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

ID	Type	Description	Link
HCH20120530-008	Other Identifier	Beijing Huanxing Cancer Hospital

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Aug 2019Actual

Completion Date

Aug 2019Actual

First Submitted Date

Aug 2, 2012

First Submission Date that Met QC Criteria

Aug 6, 2012

First Posted Date

Aug 9, 2012Estimated

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

Sep 2, 2020

Last Update Posted Date

Sep 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The investigators aim to determine the complications and risk factors related with peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer patients.

Detailed Description

The purpose of this study is to determine the complications and risk factors related with peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

3,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
complications		catheter-related venous thrombosis catheter-related infections

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Catheter-related venous thrombosis and catheter-related infections	Catheter-related venous thrombosis and catheter-related infections	30 days after PICC and CVC line withdrawn

Secondary Outcomes

Measure	Description	Time Frame
Catheter tip position	Catheter tip position	participants will be followed before PICC and CVC line withdrawn

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all adult cancer patients with central venous catheters (CVCs) or peripherally inserted central catheters (PICCs) placed at BeijingHCH.

Exclusion Criteria:

without written informed consent

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

All adult cancer patients with CVC and PICC placed at BeijingHCH and with written consent for this study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jian DING, MD	Beijing Huanxing Cancer Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Huanxing Cancer Hospital		Beijing	Beijing Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D013927	Thrombosis
D007239	Infections
D009369	Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided