UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004074 |
|---|---|
| Receipt number | R000004906 |
| Scientific Title | A study on recombinant thrombomodulin alfa in patients with disseminated intravascular coagulation (DIC) caused by sepsis receiving continuous hemodiafiltration (CHDF). |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2010/08/19 23:43:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on recombinant thrombomodulin alfa in patients with disseminated intravascular coagulation (DIC) caused by sepsis receiving continuous hemodiafiltration (CHDF).
Acronym
A study on recombinant thrombomodulin for septic DIC patients receiving CHDF.
Scientific Title
A study on recombinant thrombomodulin alfa in patients with disseminated intravascular coagulation (DIC) caused by sepsis receiving continuous hemodiafiltration (CHDF).
Scientific Title:Acronym
A study on recombinant thrombomodulin for septic DIC patients receiving CHDF.
Region
| Japan |
Condition
Condition
Disseminated intravascular coagulation (DIC)
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate pharmacokinetics of recombinant thrombomodulin for septic DIC patients receiving CHDF.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma levels of soluble thrombomodulin
Key secondary outcomes
Course of DIC score; Course of blood clotting test findings; Course of SOFA score; Course of cytokine levels; Outcome of subjects; Adverse events; Adverse drug reaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rTM is administered at at a dose of 380 U/kg/day for 6 days.
Interventions/Control_2
rTM is administered at at a dose of 130 U/kg/day for 6 days.
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. DIC patients with the first administration of rTM.
2. Septic patients who will receive CHDF for 24 hours or more after administration of rTM.
3. Written informed consent of participation.
Key exclusion criteria
1. Chronic kidney disease
2. Patients showing intracranial, pulmonary or gastrointestinal hemorrhage.
3. Patients with a history of hypersensitivity to rTM.
4. Pregnant women, nursing mothers or possibly pregnant women.
5. Other patients judged to be inappropriate at the discretion of investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Oda |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8677 Japan
TEL
043-226-2372
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Setoguchi Daisuke |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8677 Japan
TEL
043-226-2372
Homepage URL
iki_saikou@hotmail.co.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | 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
| 2010 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 19 | Day |
Last modified on
| 2010 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004906
