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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010632
Receipt No. R000012432
Scientific Title Efficacy and safety of recombinant human thrombomodulin for the patients with coagulopathy before cardiovascular surgery
Date of disclosure of the study information 2013/05/01
Last modified on 2013/05/01

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Basic information
Public title Efficacy and safety of recombinant human thrombomodulin for the patients with coagulopathy before cardiovascular surgery
Acronym Efficacy and safety of recombinant human thrombomodulin for DIC patients before cardiovascular surgery
Scientific Title Efficacy and safety of recombinant human thrombomodulin for the patients with coagulopathy before cardiovascular surgery
Scientific Title:Acronym Efficacy and safety of recombinant human thrombomodulin for DIC patients before cardiovascular surgery
Region
Japan

Condition
Condition aortic aneurysm
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of recombinant human thrombomodulin for the patients with coagulopathy after cardiovascular surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes DIC score (at the day-6 after the commence of the treatment)
Key secondary outcomes Blood clotting test findings
(FDP, Ddimer, TAT, PIC)
AT activity
CRP

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 showing intracranial, pulmonary or gastrointestinal hemorrhage.
2) Patients with serious hepatopathy such as fulminant hepatitis, uncompensated liver cirrhosis and others
3) Patients with a history of hypersensitivity to rTM.
4) Pregnant women, nursing mothers or possibly pregnant women.
Key exclusion criteria 1) Patients showing intracranial, pulmonary or gastrointestinal hemorrhage.
2) Patients with serious hepatopathy such as fulminant hepatitis, uncompensated liver cirrhosis and others
3) Patients with a history of hypersensitivity to rTM.
4) Pregnant women, nursing mothers or possibly pregnant women.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Shirasaka
Organization Kobe University Graduate School of Medicine, Kobe, Japan
Division name Department of Surgery, Division of Cardiovascular Surgery
Zip code
Address 7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL 078-382-5942
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori Shirasaka
Organization Kobe University Graduate School of Medicine, Kobe, Japan
Division name Department of Surgery, Division of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Yutaka Okita
Institute
Department

Funding Source
Organization Asahi-Kasei Pharma
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 05 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 Preinitiation
Date of protocol fixation
2013 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recombinant human thrombomodulin is administrated to the patients for 6 days
after the definite diagnosis as DIC(380 unit/kg/day).

Blood clotting test findings (FDP, D dimer, TAT, PIC) is evaluated and DIC score is calculated after the treatment.

Management information
Registered date
2013 Year 05 Month 01 Day
Last modified on
2013 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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