UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008339 |
|---|---|
| Receipt number | R000009808 |
| Scientific Title | Efficacy of recombinant human soluble thrombomodulin for disseminated intravascular coagulation (DIC) occurred in patients with severe sepsis |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2017/01/03 15:59:58 |
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Basic information
Public title
Efficacy of recombinant human soluble thrombomodulin for disseminated intravascular coagulation (DIC) occurred in patients with severe sepsis
Acronym
Efficacy of recombinant thrombomodulin for patients with severe sepsis
Scientific Title
Efficacy of recombinant human soluble thrombomodulin for disseminated intravascular coagulation (DIC) occurred in patients with severe sepsis
Scientific Title:Acronym
Efficacy of recombinant thrombomodulin for patients with severe sepsis
Region
| Japan |
Condition
Condition
Severe sepsis with disseminated intravascular coagulation (DIC)
Classification by specialty
| Medicine in general | Infectious disease | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to show that administration of recombinant human soluble thrombomodulin can increase the survival rate after the 28 hospital days and 3 month, and improve organ dysfunctions including coagulation systems for patients with severe sepsis or septic shock who fulfilled the diagnosis criteria of acute DIC and were diagnosed DIC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the survival rate after the 28 hospital days and 3 month.
Key secondary outcomes
1. SOFA score, MODS score
2. CRP value, platelet value, FDP value, D-dimer value
3. Duration of administration of catecholamine
4. Total fluid value until stopping administration of catecholamine
5. The volume of blood transfusion until 72 hours and the total volume until the discharge (RBC volume, FFP volume, platelet volume)
6. Duration of mechanical ventilation
7. The survival rate of 72 hours
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The rhTM group
When the patients with severe sepsis are diagnosed DIC (the acute DIC), they are injected intravenously with recombinant human soluble thrombomodulin (rhTM) within 24 hrs after the diagnosis.
Interventions/Control_2
The attending physician performed the standard treatment according to "Surviving sepsis campaign 2008"on the patients in both the rhTM group and the control group.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients with severe sepsis or septic shock admitted to the National Center For Global Health and Medicine, Japan
2) 1) and the patients were diagnosed DIC using the acute DIC criteria within 24 hrs after the admission.
Key exclusion criteria
1. The patients who have the need for the emergency surgery.
2. The patients and/or their family who refuse the intensive care (intratracheal intubation, mechanical ventilation, administration of catecholamine, etc.).
3. The patients who have intracranial bleeding, pulmonary hemorrhage, gastrointestinal hemorrhage (persistent hematemesis, persistent hemorrhagic stool or persistent bleeding from gastrointestinal ulcer).
4. The patients who have fulminant hepatic failure, decompensated cirrhosis, or other sever hepatic diseases.
5. The patients who have allergies to rhTM
6. The pregnant women, or the patients who have the possibility of pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiyoshi Hagiwara |
Organization
National Center For Global Health and Medicine, Japan
Division name
Emergency Medicine and Critical Care
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
03-3202-7181
ahagiwar@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiyoshi Hagiwara |
Organization
National Center For Global Health and Medicine, Japan
Division name
Emergency Medicine and Critical Care
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
03-3202-7181
Homepage URL
ahagiwar@hosp.ncgm.go.jp
Sponsor or person
Institute
The ethics committees of National Center For Global Health and Medicine, Japan
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://bmjopen.bmj.com/content/6/12/e012850.full?sid=92554706-82b6-4e0e-bd98-7027abc37a94
Number of participants that the trial has enrolled
Results
The 28-day survival rates were 84% and 83% in the control and rhTM groups, respectively (p=0.745, log-rank test). The 90-day survival rates were 73% and 72% in the control and rhTM groups, respectively (p=0.94, log-rank test). Meanwhile, the rates of recovery from DIC (<4) were significantly higher in the rhTM group than in the control group (p=0.001, log-rank test). Relative change from baseline of d-dimer levels was significantly lower in the rhTM group than in the control group, on days 3 and 5.
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
Main results already published
Date of protocol fixation
| 2012 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 04 | Day |
Last modified on
| 2017 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009808
