UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026037
Receipt number R000029927
Scientific Title Study in measurement of hardness of the intracranial hematoma
Date of disclosure of the study information 2017/02/07
Last modified on 2023/02/12 09:59:16

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Basic information

Public title

Study in measurement of hardness of the intracranial hematoma

Acronym

Study in measurement of hardness of the intracranial hematoma

Scientific Title

Study in measurement of hardness of the intracranial hematoma

Scientific Title:Acronym

Study in measurement of hardness of the intracranial hematoma

Region

Japan


Condition

Condition

Intracranial hematoma

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

analysis of pathophysiology

Basic objectives2

Others

Basic objectives -Others

To analyze the difference of the hardness of intracranial hematoma using with a hardness meter intraoperatively in patients with and without antithrombotic therapy.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Intracranial hematoma of the patients with antithrombotic therapy is hard.

Key secondary outcomes

Hematoma histology, safeness of surgery, neurological outcome


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

measurement of hardness of hematoma
one time at surgery

Interventions/Control_2

antithrombotic therapy
medicine, dose, period are not concerned

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

200 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with intracranial hematoma
Patients with written agreement for the study by him/herself or a family member under the free will after the sufficient understanding after the explanation

Key exclusion criteria

Patients whom the study chief or assistants decided not to be optimal to include the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Michiyasu
Middle name
Last name Suzuki

Organization

Yamaguchi Graduate School of Medicine

Division name

Neurosurgery

Zip code

755-8505

Address

1-1-1 Minamikogushi, Ube, Yamaguchi

TEL

0836-22-2295

Email

michi@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Sadahiro
Middle name
Last name Nomura

Organization

Yamaguchi Graduate School of Medicine

Division name

Neurosurgery

Zip code

755-8505

Address

1-1-1 Minamikogushi, Ube, Yamaguchi

TEL

0836-22-2295

Homepage URL


Email

snomura@yamaguchi-u.ac.jp


Sponsor or person

Institute

Neurosurgery, Yamaguchi Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Neurosurgery, Yamaguchi Graduate School of Medicine

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

Yamaguchi University

Address

Minamikogushi 1-1-1, Ube

Tel

0836-22-2428

Email

me223@yamaguchi-u.ac.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

2017 Year 02 Month 07 Day


Related information

URL releasing protocol

http://ds.cc.yamaguchi-u.ac.jp/~neuro-w1/index.html

Publication of results

Unpublished


Result

URL related to results and publications

http://ds.cc.yamaguchi-u.ac.jp/~neuro-w1/index.html

Number of participants that the trial has enrolled

25

Results

Hematomas in the patients having taken oral anticoagulant were tough.
Intraventricular hematomas were fragile, and intraparenchymal hematomas were tough.
The tough hematoma contained platelets and the fragile hematoma contained erythrocyte mainly.

Results date posted

2023 Year 02 Month 12 Day

Results Delayed

Delay expected

Results Delay Reason

Shortage of working time.

Date of the first journal publication of results


Baseline Characteristics

Patients with intracerebral hematoma

Participant flow

Patients admitted on our department.
Informed consent for the operation and the research was taken.
Hematoma sample was taken during the operation.

Adverse events

no

Outcome measures

It was proven that hematomas in the patients having taken oral anticoagulants were tough.

Plan to share IPD

no

IPD sharing Plan description

no


Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2016 Year 04 Month 01 Day

Date of IRB

2017 Year 02 Month 07 Day

Anticipated trial start date

2017 Year 02 Month 07 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 07 Day

Last modified on

2023 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029927


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name