UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007965
Receipt number R000009379
Scientific Title Therapeutic effects of recombinant human soluble thrombomodulin in patients with DIC caused by severe burns:a historical control clinical trial.
Date of disclosure of the study information 2012/05/16
Last modified on 2015/01/05 17:01:36

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Basic information

Public title

Therapeutic effects of recombinant human soluble thrombomodulin in patients with DIC caused by severe burns:a historical control clinical trial.

Acronym

Therapeutic effects of rhTM in patients with DIC caused by severe burns:
a historical control clinical trial.

Scientific Title

Therapeutic effects of recombinant human soluble thrombomodulin in patients with DIC caused by severe burns:a historical control clinical trial.

Scientific Title:Acronym

Therapeutic effects of rhTM in patients with DIC caused by severe burns:
a historical control clinical trial.

Region

Japan


Condition

Condition

DIC caused by severe burns

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of rhTM in patients with DIC which caused by severe burns.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Mortality in ICU (the interrelation between DIC remission rate and 28-day survival rete).

Key secondary outcomes

Mortality
Course of
DIC score
Clinical symptom
Blood clotting test
Inflammatory marker
APACHEII
HMGB1
Adverse events


Base

Study type

Interventional


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

rhTM is administered at a dose of 0.06 mg/kg/day by intravenous drip for 30 minutes. This treatment is replaced once daily for 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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient who fills everything the following
(1)DIC established by JAAM (Japanese Association for Acute Medicine) DIC criteria>=4
(2)Severe burns as underlying diseases which directly caused DIC.(Burn Index>=10).
(3)Patient who gives written informed consent.

Key exclusion criteria

(1)Patients aged < 15 years.
(2)Patients showing intracranial, pulmonary or gastrointestinal hemo- rrhage.
(3)Patients with a history of hypersensitivity to rhTM.
(4)Pregnancy or possibly pregnancy.
(5)Other patients judged to be inappropriate at the discretion of investigators.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoto Morimura

Organization

Yokohama City University Medical Center

Division name

Department of Emergency Medicine

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

molimula@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasushi Yamamoto

Organization

Yokohama City University Medical Center

Division name

Critical Care and Emergency Medical Center

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL


Email

molimula@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Medical Center

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


Email



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

横浜市立大学附属市民総合医療センター(神奈川県)


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 16 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

Terminated

Date of protocol fixation

2012 Year 01 Month 06 Day

Date of IRB


Anticipated trial start date

2012 Year 06 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

2012 Year 05 Month 16 Day

Last modified on

2015 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009379


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name