NCT05455866

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

July 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 8, 2022

Last Update Submit

July 8, 2022

Conditions

Central Venous Catheter ThrombosisCentral Venous Catheter Related Bloodstream InfectionSolid TumorHematologic Malignancy

Outcome Measures

Primary Outcomes (1)

  • Incidence rate and density of central venous catheter-related complications (infections, thromboses, extravasation)

    6 months

Secondary Outcomes (1)

  • Incidence rate of severe central venous catheter-related complications

    6 months

Interventions

central venous catheterDEVICE

collection and descriptionof central venous catheter-related complications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients at Oncohematology Outpatient Department

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Upper Extremity Deep Vein ThrombosisHematologic Neoplasms

Interventions

Central Venous Catheters

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Vascular Access DevicesCathetersEquipment and Supplies

Study Officials

  • Florence OBERKAMPF

    Centre Hospitalier Alpes Leman

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence OBERKAMPF

CONTACT

+33 4 50 82 22 72foberkampf@ch-alpes-leman.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 13, 2022

Study Start

July 11, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

July 13, 2022

Record last verified: 2022-07