Critically IllTHROMBOCATNCT03157245
Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery
An observational study of Critically Ill and Central Venous Catheter Thrombosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The objective is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Central Venous Catheter Thrombosis, PARENTERAL NUTRITION
- What is being tested?
- DOPPLER ULTRASOUND
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2017to 31 May 2019
- 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: Patient > 18 years old, admitted in surgical critical care, immediatly after elective carcinologic surgery with a central venous catheter for parenteral nutrition
Who may be able to join
- Hospitalization in surgical intensive care in the immediate post-operative period
- surgery for cancer
- central venous catheter placement for parenteral nutrition
- written consent dated and signed before doppler examination
Who cannot join
- patient < 18 years old
- pregnancy
- surgery with no indication for parenteral nutrition on central venous access
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
NOVY
Vandœuvre-lès-Nancy, 54500
Emmanuel NOVY, MD, +33 383157437, e.novy@chru-nancy.fr
Jean Pierre PERTEK, MD, +33 383157398, jp.pertek@chru-nancy.fr
About this study
Official title: Interest of Doppler Ultrasound for the Assessment of Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery
The objective is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.
Read the detailed description
The post operative period, wich is a critically ill condition, and history of cancer are related to a high risk of venous thrombosis. Catheter is one of the most common complication of parenteral nutrition and is also related to thrombosis.
The combination of theses conditions increases the risk of venous catheter thrombosis. , Since, there is no data evaluating this risk nowadays, the objective of this study is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.
- Being tested
- DOPPLER ULTRASOUND
- Medical subject headings
- Critical Illness, Upper Extremity Deep Vein Thrombosis, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOPPLER ULTRASOUNDDiagnostic test
MESURE OF THE PRESENCE OR NOT OF A CATHETER RELATED VEIN THROMBOSIS
| Study group | Role | What they receive |
|---|---|---|
| participant | Not described Receives: Diagnostic Test: DOPPLER ULTRASOUND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or no of a catheter related thrombosis
Patients will undergo an examination by a specialist in vascular medicine just before removal of the catheter.This specialist also is specialist in vascular doppler ultrasonography.
The specialist would search symptoms and signs of deep vein thrombosis : local pain, swelling, redness, warmth. Clinical examinated would be completed by doppler ultrasound : thrombus is detected during a compression test, while cruor is evaluated in B-mode (gray-scale) imaging. This method is very sensitive with regard to detection of the thrombus.
Measured: 1 day (day of the catheter removal)
Secondary outcomes (1)
clinical factors associated with the presence of catheter related thrombosis
During the intensive care unit stay, the investigator would prospectively collected data, including :
- potential risk factors : age, history of venous thrombosis, type of cancer...
- details of surgery : type and operating time
- details of critically ill period : number and type of organs failures, first mobilisation..
- details of the clinical course : occurence of a situation requiring curative anticoagulation..
Measured: post operative period, during the intensive care unit stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start2 Jun 2017
- Primary completion31 May 2018 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157245
- Sponsor's protocol ID
- 2017-A00043-50
- Acronym
- THROMBOCAT
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Doppler Ultrasound for the Assessment of Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery
- ClinicalTrials.gov ID
- NCT03157245
- Acronym / sponsor ID
- THROMBOCAT / 2017-A00043-50
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 17 May 2017 (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.
The objective is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.
Detailed description
The post operative period, wich is a critically ill condition, and history of cancer are related to a high risk of venous thrombosis. Catheter is one of the most common complication of parenteral nutrition and is also related to thrombosis.
The combination of theses conditions increases the risk of venous catheter thrombosis. , Since, there is no data evaluating this risk nowadays, the objective of this study is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participant | – | Diagnostic Test: DOPPLER ULTRASOUND |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient > 18 years old, admitted in surgical critical care, immediatly after elective carcinologic surgery with a central venous catheter for parenteral nutrition
Key inclusion criteria (4 listed)
- Hospitalization in surgical intensive care in the immediate post-operative period
- surgery for cancer
- central venous catheter placement for parenteral nutrition
- written consent dated and signed before doppler examination
Key exclusion criteria (3 listed)
- patient < 18 years old
- pregnancy
- surgery with no indication for parenteral nutrition on central venous access
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 |
|---|---|---|
| DOPPLER ULTRASOUNDMESURE OF THE PRESENCE OR NOT OF A CATHETER RELATED VEIN THROMBOSIS | Diagnostic test | participant |
Primary outcome
Presence or no of a catheter related thrombosis
Time frame: 1 day (day of the catheter removal)
Patients will undergo an examination by a specialist in vascular medicine just before removal of the catheter.This specialist also is specialist in vascular doppler ultrasonography. The specialist would search symptoms and signs of deep vein thrombosis : local pain, swelling, redness, warmth. Clinical examinated would be completed by doppler ultrasound : thrombus is detected during a compression test, while cruor is evaluated in B-mode (gray-scale) imaging. This method is very sensitive with regard to detection of the thrombus.
1 secondary outcome
clinical factors associated with the presence of catheter related thrombosis
Time frame: post operative period, during the intensive care unit stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Central Venous Catheter Thrombosis, run by Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 3 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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or no of a catheter related thrombosis (time frame: 1 day (day of the catheter removal)). 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 8 Jun 2017.