UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery
Title of the study (Brief title)	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	Michiaki Unno
Organization	Tohoku University Hospital
Division name	Hepato-Biliary Pancreatic surgery,
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Email	m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Yu Katayose
Organization	Tohoku University Hospital
Division name	Hepato-Biliary Pancreatic surgery,
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Homepage URL
Email	kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011141