Central Venous Catheter ThrombosisKTcCHONCT05455866
Central Venous Catheter-related Complications in Patients Under Anticancer Treatment
An observational study of Central Venous Catheter Thrombosis and Central Venous Catheter Related Bloodstream Infection, run by Centre Hospitalier Alpes Leman.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter Thrombosis, Central Venous Catheter Related Bloodstream Infection, Solid Tumor
- What is being tested?
- central venous catheter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2022to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients at Oncohematology Outpatient Department
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Central Venous Catheter-related Complications in Patients Under Anticancer Treatment: a Prospective Monocentric Study on Incidence and Consequences
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
- Conditions
- Central Venous Catheter Thrombosis, Central Venous Catheter Related Bloodstream Infection, Solid Tumor, Hematologic Malignancy
- Being tested
- central venous catheter
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheterDevice
collection and descriptionof central venous catheter-related complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate and density of central venous catheter-related complications (infections, thromboses, extravasation)
Measured: 6 months
Secondary outcomes (1)
Incidence rate of severe central venous catheter-related complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start11 Jul 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous Catheter ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Alpes Leman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence OBERKAMPF, Principal investigator, Centre Hospitalier Alpes Leman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455866
- Sponsor's protocol ID
- KTcCHO
- Acronym
- KTcCHO
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Catheter-related Complications in Patients Under Anticancer Treatment: a Prospective Monocentric Study on Incidence and Consequences
- ClinicalTrials.gov ID
- NCT05455866
- Acronym / sponsor ID
- KTcCHO / KTcCHO
- Conditions
- Central Venous Catheter Thrombosis, Central Venous Catheter Related Bloodstream Infection, Solid Tumor, Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Alpes LemanUniversity, hospital or other
- Study start
- 11 Jul 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients at Oncohematology Outpatient Department
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| central venous cathetercollection and descriptionof central venous catheter-related complications | Device | – |
Primary outcome
Incidence rate and density of central venous catheter-related complications (infections, thromboses, extravasation)
Time frame: 6 months
1 secondary outcome
Incidence rate of severe central venous catheter-related complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence OBERKAMPF principal investigator
Centre Hospitalier Alpes Leman
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter Thrombosis and Central Venous Catheter Related Bloodstream Infection, run by Centre Hospitalier Alpes Leman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence OBERKAMPF (+33 4 50 82 22 72, foberkampf@ch-alpes-leman.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate and density of central venous catheter-related complications (infections, thromboses, extravasation) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.