UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020358 |
|---|---|
| Receipt number | R000023516 |
| Scientific Title | Preliminary study on recombinant human soluble thrombomodulin (rTM) administration for treatment of pneumonia-induced acute respiratory distress syndrome (ARDS) complicated with disseminated intravascular coagulation(DIC) and sepsis, including avian influenza virus infection |
| Date of disclosure of the study information | 2015/12/28 |
| Last modified on | 2019/03/29 06:17:21 |
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Basic information
Public title
Preliminary study on recombinant human soluble thrombomodulin (rTM) administration for treatment of pneumonia-induced acute respiratory distress syndrome (ARDS) complicated with disseminated intravascular coagulation(DIC) and sepsis, including avian influenza virus infection
Acronym
Recombinant human soluble thrombomodulin (rTM) for treatment of pneumonia-induced ARDS complicated with DIC and sepsis, including avian influenza virus infection
Scientific Title
Preliminary study on recombinant human soluble thrombomodulin (rTM) administration for treatment of pneumonia-induced acute respiratory distress syndrome (ARDS) complicated with disseminated intravascular coagulation(DIC) and sepsis, including avian influenza virus infection
Scientific Title:Acronym
Recombinant human soluble thrombomodulin (rTM) for treatment of pneumonia-induced ARDS complicated with DIC and sepsis, including avian influenza virus infection
Region
| Asia(except Japan) |
Condition
Condition
Pneumonia-induced acute respiratory distress syndrome (ARDS) complicated with disseminated intravascular coagulation(DIC) and sepsis, including avian influenza virus infection
Classification by specialty
| Pneumology | Infectious disease | Pediatrics |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the clinical course and change of plasma thrombomodullin concentration after administration of rTM for treating pneumonia-induced ARDS complicated with DIC and sepsis, including avian influenza virus infection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of plasma thrombomodullin concentration
Key secondary outcomes
1. Observation of clinical course
1.1. Status of DIC
(1) DIC score(ISTH)
(2) Bleeding symptoms
(3) Vital signs and physical examination findings
(4) Other laboratory findings; e.g. proinflammatory cytokines
1.2. Status of ARDS
(1) P/F ratio
(2) Duration of fever
(3) Duration of mechanical ventilation including CPAP
(4) Vital signs, physical examination findings and SpO2
(5) Chest X ray findings
Extent of infiltration: 0=No infiltration, 1=Unilateral, 2=bilateral
(6) Other laboratory findings; e.g. blood gas analysis
1.3. The change of liver function and renal function
2. Outcome
3. The etiology of pneumonia-induced ARDS complicated with DIC and sepsis
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
Drip infusion of 380 U/kg of rTM q24 hours for maximum 6 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
| 1 | months-old | <= |
Age-upper limit
| 180 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Severe ARDS complicated with DIC and sepsis. Patients who fulfill all of the followings (1-5) within 72 hours from PICU admission
1) The patients who admitted the PICU-NHP
2) Age: 1 month -15 years old
3) DIC score is within ISTH DIC criteria (Score 5 or more).
4) PaO2/FiO2 ratio (P/F ratio) less than 100 mmHg in arterial blood gas analysis.
5) No severe left ventricular dysfunction
6) Chest X ray abnormal shadow (consolidation, ground-glass opacity, or nodular shadow)
7) Patients provide written informed consent prior to initiation of any study procedures. Patients who or whose attorney are able to understand and comply with planned study procedures.
2.Avian influenza virus infection induced ARDS complicated with DIC and sepsis. Patients who fulfill all of the followings (1-9) within 72 hours from PICU admission
1) Contact with sick or dead poultry
2) Positive result of rapid diagnostic test for influenza A, or avian influenza viral genomes are positive with PCR.
3) Patients with 2 or more of the following symptoms.
Fever, Cough, Dyspnea, Sore throat, Nasal congestion or rhinorrhea, Headache, Myalgia or arthralgia
4) The patients who admitted the PICU-NHP
5) Age: 1 month -15 years old
6) DIC score is within ISTH DIC criteria (Score more more than 5)
7) PaO2/FiO2 ratio (P/F ratio) less than 300 mmHg in arterial blood gas analysis
8) Chest X ray abnormal shadow (consolidation, ground-glass opacity, or nodular shadow)
9) Patients provide written informed consent prior to initiation of any study procedures. Patients who or whose attorney are able to understand and comply with planned study procedures.
Key exclusion criteria
Patients who fulfill any of the followings are excluded
1. Patients with severe renal dysfunction (creatinine clearance < 10mL/min)
2. Patients with bleeding symptoms.
3. Patients whom the treating doctor deems, for any reason, to be ineligible.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Nakajima |
Organization
National Institute of Infectious diseases
Division name
department of pathology
Zip code
1628640
Address
Toyama 1-23-1, Shinjuku-ku, Tokyo, 162-8640, Japan
TEL
+81-2-5285-1111
tenko@nih.go.jp
Public contact
Name of contact person
| 1st name | Jin |
| Middle name | |
| Last name | Takasaki |
Organization
National Center for Global Health and Medicine
Division name
Department of respiratory medicine
Zip code
1628655
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL
+81-3-3202-7181
Homepage URL
jintakajj@gmail.com
Sponsor or person
Institute
National Hospital for Pediatrics, Nanoi, Vietnam
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee NCGM
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
Tel
+81-3-3202-7181
rinrijm@hosp.ncgm.go.jp
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
| 2015 | Year | 12 | Month | 28 | 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
| 2015 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 05 | 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
| 2015 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023516
