UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041484
Receipt number R000047364
Scientific Title Synergetic/additive neuroprotection of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion
Date of disclosure of the study information 2020/08/21
Last modified on 2021/08/24 19:03:25

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Basic information

Public title

The Safety and synergetic/additive neuroprotective effect of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion

Acronym

The Safety and synergetic/additive neuroprotective effect of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion

Scientific Title

Synergetic/additive neuroprotection of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion

Scientific Title:Acronym

Synergetic/additive neuroprotection of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion

Region

Japan


Condition

Condition

Acute encephalopathy with biphasic seizures and late reduced diffusion or suspected

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

he aim of this trial is to examine the safety and the synergetic/additive neuroprotective effect of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion compared to the historical prognostic data.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

The prevalence of adverse effects in patients with AESD with RIPoC.
The neurological outcomes at 1, 3,6, 12 months, 2 years and 3 years from disease onset were assessed using the PCPC score, from medical records by two paediatricians for each patient including the results of the neurodevelopment evaluation by the Kyoto Scale of Psychological Development 2001, the Tanaka-Binet Intelligence Test, or the WISC-IV, and for each patient, Vineland Adaptive Behavior Scales second edition.

Key secondary outcomes

The association between the MRI findings (distribution of brain lesions on the MRI (hemisphere, bilateral frontal lobe, or others); presence of basal ganglia/thalamus lesions, fractional anisotrophy (FA) in the white matter) and the prognosis at 1, 3,6, 12 months, 2 years and 3 years from disease onset were assessed using the PCPC score, from medical records by two paediatricians for each patient including the results of the neurodevelopment evaluation by the Kyoto Scale of Psychological Development 2001, the Tanaka-Binet Intelligence Test, or the WISC-IV, and for each patient, Vineland Adaptive Behavior Scales second edition among the patients.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

RIPoC (4 cycles of inflation 5 mins and deflation 5 mins) applied on a lower extremity using a blood pressure monitor cuff with 200 mmHg.

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

192 months-old >

Gender

Male and Female

Key inclusion criteria

Patients diagnosed as having AESD or
strongly suspected judging from clinical symptoms/signs (seizures and consciousness disturbance), brain MRI, and electroencephalogram findings. Patients who are being applied therapeutic hypothermia without high intensity area in the white matter are also included.

Key exclusion criteria

Patients who the consent is not gained from their parent/parents or guardians for the study.
Patients with thrombocytopenia (<100,000/uL), coagulation disorders (international normalised ratio of prothrombin time > 1.3 s or activated partial thromboplastin time > 50 s).
Patients with shock, or unstable hemodynamic status with elevated intracranial hypertension symptoms, requiring catecholamine medications or antihypertensive medications
Patients with injuries or skin inflammation on both lower extremities which prevent the application of a blood pressure monitor cuff.

Target sample size

14


Research contact person

Name of lead principal investigator

1st name Go
Middle name
Last name Kawano

Organization

St Mary's Hospital

Division name

Paediatrics

Zip code

830-8543

Address

422 Tsubukuhonmachi, Kurume, Fukuoka 830-8543, Japan

TEL

0942-35-3322

Email

Kawano19720625@yahoo.co.jp


Public contact

Name of contact person

1st name Go
Middle name
Last name Kawano

Organization

St Mary's Hospital

Division name

Paediatrics

Zip code

830-8543

Address

422 Tsubukuhonmachi, Kurume, Fukuoka 830-8543, Japan

TEL

0942-35-3322

Homepage URL


Email

Kawano19720625@yahoo.co.jp


Sponsor or person

Institute

Paediatrics, St Mary's Hospital

Institute

Department

Personal name



Funding Source

Organization

self funding

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

St Mary's Hospital

Address

422 Tsubukuhonmachi, Kurume, Fukuoka 830-8543, Japan

Tel

0942-35-3322

Email

Kawano19720625@yahoo.co.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

聖マリア病院


Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 21 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

Open public recruiting

Date of protocol fixation

2020 Year 04 Month 10 Day

Date of IRB

2020 Year 04 Month 10 Day

Anticipated trial start date

2020 Year 04 Month 10 Day

Last follow-up date

2026 Year 09 Month 30 Day

Date of closure to data entry

2026 Year 09 Month 30 Day

Date trial data considered complete

2026 Year 09 Month 30 Day

Date analysis concluded

2026 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2020 Year 08 Month 20 Day

Last modified on

2021 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047364


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name