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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015105
Receipt No. R000017582
Scientific Title A randomized phase 2 trial which investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.
Date of disclosure of the study information 2014/09/10
Last modified on 2019/04/08

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Basic information
Public title A randomized phase 2 trial which investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.
Acronym A randomized phase 2 trial of AT-III products in infectious DIC.
Scientific Title A randomized phase 2 trial which investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.
Scientific Title:Acronym A randomized phase 2 trial of AT-III products in infectious DIC.
Region
Japan

Condition
Condition advanced hepatobiliary and pancreatic cancer patients
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A randomized phase 2 trial was conducted in order to investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes AT-III activity after 72 hours
Key secondary outcomes 1) DIC score after 72 hours
2) DIC score after 7 days
3) SIRS score after 72 hours
4) pyrexia rate at the time of 24 hours and 72 hours later

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 500 IU of AT-III, 60 min. intravenous infusion, 3 times every 8 hours
Interventions/Control_2 1,500 IU of AT-III, 60 min. intravenous infusion in a day
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) advanced hepatobiliary and pancreatic cancer patients
2) acute DIC
3) AT-III activity less than 70%
4) PS 0-2 adults with informed concent with cocuments
Key exclusion criteria pregnat or possible pregnat women
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Ioka
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Medical Oncology
Zip code
Address 3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL 06-6972-1181
Email ioka-ta@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Ioka
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Medical Oncology
Zip code
Address 3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL 06-6972-1181
Homepage URL
Email ioka-ta@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology
Institute
Department

Funding Source
Organization Osaka foundation for the prevention of cancer and cardiovascular diseases data center
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 09 Month 10 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 Terminated
Date of protocol fixation
2007 Year 01 Month 01 Day
Date of IRB
2007 Year 03 Month 01 Day
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 10 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017582

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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