UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051555 |
|---|---|
| Receipt number | R000058821 |
| Scientific Title | A study of the association between postoperative venous thromboembolism and protein S specific activity. |
| Date of disclosure of the study information | 2023/07/08 |
| Last modified on | 2023/07/08 13:57:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of the association between postoperative venous thromboembolism and protein S specific activity.
Acronym
A study of the association between postoperative venous thromboembolism and protein S specific activity.
Scientific Title
A study of the association between postoperative venous thromboembolism and protein S specific activity.
Scientific Title:Acronym
A study of the association between postoperative venous thromboembolism and protein S specific activity.
Region
| Japan |
Condition
Condition
Venous thromboembolism (deep venous thromboembolism, pulmonary thromboembolism)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Deep vein thrombosis in the perioperative period is a serious complication, one of which is pulmonary embolism, which can lead to shock and sudden death. Despite standard prophylaxis, it still occurs, and its exact cause remains unknown. In this study, we will clarify the relationship with protein S ratio activity, which is considered one of the possible causes of venous thrombosis in the perioperative period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Protein S protein levels, activity, and specific activity in patients who develop VTE.
Key secondary outcomes
Investigation of the relationship between protein S specific activity and other coagulation factor markers.
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 with postoperative VTE
(2) Patients who have obtained written consent for participation in this study from the research subject or a surrogate.
(3) Patients who are at least 20 years of age at the time consent is obtained.
Key exclusion criteria
(1) Patients who did not give their consent
(2) Patients who did not undergo blood tests
(3) Patients who are (or will be) using unapproved drugs such as investigational drugs
(4) Other patients whom the investigator deems inappropriate as research subjects.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Yamaura |
Organization
Kyushu University
Division name
Anesthesiology and critical care medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN
TEL
092-642-5714
masuika@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Nakagawa |
Organization
Kyushu University Hospital
Division name
operating rooms
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN
TEL
092-642-5714
Homepage URL
anestack1015@gmail.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
self
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
KYUSHU UNIVERSITY Center for Clinical and Translational Research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2023 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Patients who have undergone surgery at Kyushu University Hospital or at a collaborating hospital and meet the eligibility criteria for research subjects will be informed in writing of their consent to participate in this study, after providing the individual with an explanation in accordance with the attached explanatory document.
(2) Patients whose consent has been obtained will be enrolled as research subjects, and the following information will be obtained from their medical records.
Information to be obtained
Age, gender, height, weight, current medical history, medical history, regular medications, surgical procedure (postoperative), blood test results (PT, APTT, blood count, FDP, D-dimer, TAT, PIC,), and leg vein echo
(3) In addition to the 15 ml of blood drawn during the usual medical examination, an additional 5 ml of blood will be drawn for research purposes.
Blood samples will be drawn twice, once at the time of VTE diagnosis and once at the time of discharge from the hospital.
(3) Samples, medical information, and personal information will be anonymized using a correspondence table.
(4) The collaborative research institute will send the specimens to an outside testing company for analysis of protein S specific activity, and the test results sent by the outside testing company and the medical information of the patients anonymized by the collaborative research institute will be sent to Kyushu University.
(5) Kyushu University will also send specimens to an external testing company and request analysis of protein S specific activity. Kyushu University will collect the medical information and test results sent from each collaborating institution.
Management information
Registered date
| 2023 | Year | 07 | Month | 08 | Day |
Last modified on
| 2023 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058821
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
