UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012590 |
|---|---|
| Receipt number | R000014726 |
| Scientific Title | The retrospective study of treatment by thrombomodulin for acute exacerbations of idiopathic pulmonary fibrosis, acute respiratory distress sydmrome |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2013/12/16 11:41:29 |
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Basic information
Public title
The retrospective study of treatment by thrombomodulin for acute exacerbations of idiopathic pulmonary fibrosis, acute respiratory distress sydmrome
Acronym
The treatment of thrombomodulin for acute respiratory failure
Scientific Title
The retrospective study of treatment by thrombomodulin for acute exacerbations of idiopathic pulmonary fibrosis, acute respiratory distress sydmrome
Scientific Title:Acronym
The treatment of thrombomodulin for acute respiratory failure
Region
| Japan |
Condition
Condition
acute exacerbations of idiopathic pulmonary fibrosis, acute respiratory distress syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the additional administration of rhTM for AE-IPF-patients has any beneficial effects on outocome, inflammatory mediators and activated coagulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The outcomes of patients included the 28-day mortality and in-hospital mortality after beginning treatment with rhTM were compared with those of untreated patients.
Key secondary outcomes
We investigated whether or not they showed any improvement in oxygenation (SpO2/FIO2) and intravascular coagulation disturbance (TAT, FDP) in the acute phase.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Thrombomodulin
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The diagnosis of AE-IPF was based on the criteria, which state that all of the following three conditions must be satisfied during the course of IPF with an unexplained worsening of dyspnea within one month: (1) increased dyspnea, (2) new HRCT appearance, (3) greater than 10-mmHg decreases in oxygen partial pressure (PaO2) in the resting arterial blood compared to previous measurements. The typical HRCT appearance of AE-IPF involved ground glass opacity and/or consolidation as a new appearance on honeycombing. The criteria for the diagnosis of ARDS, as set by the Berlin Definition
Key exclusion criteria
The AE-IPF-patients were excluded if they had obvious signs of infection, preexisting pulmonary embolisms, left heart failure, pulmonary hypertension due to pulmonary thromboemboli or phlebitis based on the findings of color Doppler ultrasonography or enhanced HRCT.
Patient or family refusal for invasive mechanical ventilation was an exclusionary criterion for endotracheal intubation. Such patients were excluded from this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Tatsumi |
Organization
Chiba University
Division name
Department of Respirology, Graduate School of Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba 260-8670 Japan
TEL
043-226-2800
tatsumi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Tsushima |
Organization
Chiba University
Division name
Department of Respirology, Graduate School of Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba 260-8670 Japan
TEL
043-226-2800
Homepage URL
tsushimakenji@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Respirology, Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
ShinonoiGeneral Hospital
First Department of Internal Medicine, Shinshu University School of Medicine
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
| 2014 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2013 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014726
