UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009983 |
|---|---|
| Receipt number | R000011141 |
| Scientific Title | Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery |
| Date of disclosure of the study information | 2013/02/06 |
| Last modified on | 2017/12/24 18:09:18 |
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Basic information
Public title
Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery
Acronym
Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery
Scientific Title
Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery
Scientific Title:Acronym
Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery
Region
| Japan |
Condition
Condition
Possibly operative cases of Hepato-Biliary-Pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We intended to verify the safety of the recombinant human thrombomodulin (rTM) for DIC after Hepato-Biliary-Pancreatic surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety of the recombinant human thrombomodulin (rTM) for DIC after Hepato-Biliary-Pancreatic surgery
Key secondary outcomes
Liver failure(ISGLS)
bleeding
transfusion
recovery rate of DIC
SOFA
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administeration of the recombinant human thrombomodulin
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Possibly resectable hepato-biliary-pancreatic tumor
2. written informed consent
3. over 20years old and below 80 years old
4. PS(ECOG); 0 and 1
5. survival of more than 3 months
6. Tolerable organ function as below
WBC >=3,000 /mm3
Neutrocyte>= 1,500/mm3
Platelet>=100,000 /mm3
Hb>=9.0g/dL
Total bilirubin: within 1.5 times of normal limit
AST, ALT, ALP: within 5 times of normal limit
creatinine: within 1.5 times of normal limit
Key exclusion criteria
1. severe bleeding (intracranial bleeding, GI bleeding, Lung bleeding)
2. Patients are likely to cause life-threatening bleeding
3. Patients with a history of cerebrovascular bleeding within one year of
4. not long after the surgery of the central nervous system and trauma
5. Patients with a history of hypersensitivity to heparin or unfractionated protein preparation
6.Pregnant or supposed to be pregnant patient
7. Early death is estimated as well as restored the DIC, the patient seems to be difficult to obtain the data and ensure the efficacy and safety of the investigational drug administration period sufficient
8. Patients were deemed inappropriate investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic surgery,
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
m_unno@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Katayose |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic surgery,
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
kein_h11@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hepato-Biliary Pancreatic surgery, Tohoku University Hospital
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
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
東北大学病院 肝胆膵外科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 06 | 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
| 2012 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 06 | Day |
Last modified on
| 2017 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011141
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
