UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006642 |
|---|---|
| Receipt number | R000007857 |
| Scientific Title | Assesment of changes of coagulatory/ fibrinolysis factors after major hepatectomy or pancreatoduodenectomy |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2011/11/01 14:09:25 |
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Basic information
Public title
Assesment of changes of coagulatory/ fibrinolysis factors after major hepatectomy or pancreatoduodenectomy
Acronym
Assesment of changes of coagulatory/ fibrinolysis factors after major hepatectomy or pancreatoduodenectomy
Scientific Title
Assesment of changes of coagulatory/ fibrinolysis factors after major hepatectomy or pancreatoduodenectomy
Scientific Title:Acronym
Assesment of changes of coagulatory/ fibrinolysis factors after major hepatectomy or pancreatoduodenectomy
Region
| Japan |
Condition
Condition
Biliary tract carcinoma
Hepatocellular carcinoma
Pancreas cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The elucidation of coagulopathy in massive bleeding
Basic objectives2
Others
Basic objectives -Others
Establishment of transfusion theraphy in massive bleeding
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FDP D dimer fibrinogen PT APTT platelet PIC TAT ADAMTS13 factor7 factor13 VWF
Key secondary outcomes
intra-operative bleeding
volume of transfusion
operation time
blood examination
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
Patients who fulfilled the criteria and agreed with the enrollment in this study
Key exclusion criteria
Patients who reject to be enrolled in this study
Patients who do not fulfill the criteria of this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya university Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich
TEL
052-744-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya university Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nagoya university Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collected blood samples of at the following time points; pre-operation, post-resection, post-operation,first,second,fourth,seventh and fifteenth postoperative days.
Management information
Registered date
| 2011 | Year | 11 | Month | 01 | Day |
Last modified on
| 2011 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007857
