UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006738 |
|---|---|
| Receipt number | R000007934 |
| Scientific Title | Clinical efficacy of Thrombomodulin alfa in hematological malignancy with disseminated intravascular coagulation |
| Date of disclosure of the study information | 2011/11/16 |
| Last modified on | 2015/01/14 12:07:49 |
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Basic information
Public title
Clinical efficacy of Thrombomodulin alfa in hematological malignancy with disseminated intravascular coagulation
Acronym
TA-HA
Scientific Title
Clinical efficacy of Thrombomodulin alfa in hematological malignancy with disseminated intravascular coagulation
Scientific Title:Acronym
TA-HA
Region
| Japan |
Condition
Condition
hematological malignancies with DIC showing decreasing fibrinogen (100mg/dl)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
establishment of thrombomodulin in hematological malignancies
Basic objectives2
Others
Basic objectives -Others
analysis of blood test including CBC, chemistry, coagulation, PDMP, and HMGB1 and clinical effect under thrombomodulin treatment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
time-dependent change regarding DIC score, clinical manifestation, data of coagulation, PDMP, and HMGB1
Key secondary outcomes
clinical outcome, total dose of transfusion (RCC, platelet, and FFP), adverse events during observation duration
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
Thrombomodulin alfa is given as 380U/Kg of 30 minute div. Treatment duration is decided by the physicians. Observation duration is from the time of administration of thrombomodulin alfa to the time of discharge, or 28 days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) the hematological malignancy patients with fibrinogen less than 100mg/dl, compatible with DIC criteria of old the Ministry of Health & Welfare. But, the hematological malignancy patients with fibrinogen more than 100mg/dl are not restricted if the physicians require the administration of thrombomodulin alfa.
2) The agreed patients or families with their own decisions under the sufficient explanation by the physicians.
Key exclusion criteria
1) the patients with severe bleeding such as brain, lung, and digestive tract
2) the patients with history of anaphylaxis to the contents in thrombomodulin alfa
3)
4) the inappropriate patients decided by the physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Kizaki |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of hematology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3471
tokuhira@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michihide Tokuhira |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of hematology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3471
Homepage URL
tokuhira@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
埼玉医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 16 | 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
| 2011 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 16 | Day |
Last modified on
| 2015 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007934
