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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name