UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035201 |
|---|---|
| Receipt number | R000040122 |
| Scientific Title | Catheter related thrombosis in the patients central venous catheter and pulmonary artery catheter are inserted |
| Date of disclosure of the study information | 2018/12/10 |
| Last modified on | 2025/12/18 14:19:37 |
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Basic information
Public title
Catheter related thrombosis in the patients central venous catheter and pulmonary artery catheter are inserted
Acronym
CRT in the patients CVC and PAC are inserted
Scientific Title
Catheter related thrombosis in the patients central venous catheter and pulmonary artery catheter are inserted
Scientific Title:Acronym
CRT in the patients CVC and PAC are inserted
Region
| Japan |
Condition
Condition
Patients after cardiovascular surgery
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence, onset time, risk factor of catheter-related thrombosis (CRT) in patients undergoing cardiovascular surgery with CVC and PAC inserted in the same internal jugular vein
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Formation of CRT
Key secondary outcomes
Time of formation, size, characteristics, risk factor etc. of CRT
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients in whom CVC and PAC were both inserted in the same internal jugular vein after introduction of general anesthesia in cardiovascular surgery at Tokyo Women's Medical University Hospital
2.Patients who got adequate explanation for participation in this study and written consent was obtained
Key exclusion criteria
1.Patients whose CVC and PAC are inserted through left and right internal jugular veins separately
2.Patients who already had CVC and/or PAC before induction
3.Patients who have already had a thrombus formation in the internal jugular vein
4.Patients whose research managers judged inappropriate as research subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nomura |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Intensive Care Unit
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku, Tokyo, Japan
TEL
03-3353-8111
nomur@crocus.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Idei |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Intensive Care Unit
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku, Tokyo, Japan
TEL
0333538111
Homepage URL
masafumi203@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Tokyo Womens Medical University
Address
8-1, Kawada-cho, Shinjuku, Tokyo, Japan
Tel
0333538111
ohta.megumi@twmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00380-021-01955-3
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00380-021-01955-3
Number of participants that the trial has enrolled
50
Results
CRT was detected in 39 of 50 patients (78%), typically forming within 1 day after catheter insertion.
The median PAC placement duration was 3 days, with a median maximum CRT diameter of 12 mm.
Significant RIJV obstruction (>50%) occurred in 10% of patients, including complete occlusion in 2%.
Platelet count, PAC duration, and intraoperative blood loss were identified as risk factors for CRT.
Results date posted
| 2025 | Year | 12 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study recruited patients aged 20 years or older who had both CVC and PAC inserted through the RIJV during cardiovascular surgery and were admitted to our ICU.
Participant flow
Adult patients who underwent cardiovascular surgery with both a central venous catheter (CVC) and a pulmonary artery catheter (PAC) inserted via the right internal jugular vein (RIJV) and were admitted to our ICU were enrolled.
All catheters were inserted under ultrasound guidance after induction of general anesthesia.
After ICU admission, patients underwent daily ultrasonographic evaluation of the RIJV to detect catheter-related thrombosis (CRT) until PAC removal.
When CRT was identified, catheters were removed as early as clinically feasible, and patients were followed with serial ultrasonography and anticoagulation therapy as indicated.
Adverse events
none
Outcome measures
Incidence, size, and risk factors of catheter-related thrombosis (CRT)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the incidence, onset time, risk factor of catheter-related thrombosis (CRT). In addition, we survey and analyze patients' background and clinical course.
Management information
Registered date
| 2018 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040122
