UMIN-CTR Clinical Trial

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
Last 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
Email	tenko@nih.go.jp

Public contact
1st 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
Email	jintakajj@gmail.com

Sponsor
Institute	National Hospital for Pediatrics, Nanoi, Vietnam
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023516