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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024675
Receipt No. R000027934
Scientific Title Comparisons of Endoscopic surgery and medical treatment for hypertensive thalamic hemorrhage
Date of disclosure of the study information 2016/11/01
Last modified on 2016/11/10

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Basic information
Public title Comparisons of Endoscopic surgery and medical treatment for hypertensive thalamic hemorrhage
Acronym Comparisons of Endoscopic surgery and medical treatment for hypertensive thalamic hemorrhage
Scientific Title Comparisons of Endoscopic surgery and medical treatment for hypertensive thalamic hemorrhage
Scientific Title:Acronym Comparisons of Endoscopic surgery and medical treatment for hypertensive thalamic hemorrhage
Region
Japan

Condition
Condition Hypertensive thalamic hemorrhage
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the efficacy and results of endoscopic surgery compared with medical treatment for hypertensive thalamic hemorrhage.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Outcome evaluation with modified Rankin Scale and Glasgow Outcome Scale at 6 months.
2) Outcome evaluation with FIM and Brunnstrom stage at 6 months.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1)Medical treatment group
All patients recieved antifibrinolytic agents, antiheypertensive substances and rehabilitation therapy. External ventricular drainage or VP shunt are not prohibit.
Interventions/Control_2 2)Endoscopic surgery group
Surgery was performed on the patients in the prone position under general anesthesia within 48 hours from onset. MRI navigation was used. We aimed to remove over 50% volume of the hematoma. Post-operative treatment was followed to medical treatment 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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) The patient's age was between 20 and 80 years.
2) Gender unquestioned.
3) The patients GCS 9 to 13. Or, The patients over GCS 14 with neurological deficit.
4) The volume of the hematoma was greater than 10ml.
5) The interval between stroke and start of treatment was less than 48 hours.
6) The patients take anti-platelet agent or anti-coagulate agent were not excluded.
Key exclusion criteria 1) GCS,<8
2) Non-hyper tensive thalamic hemorrhage (aneurysmal or alteriovenous hemorrhage, postraumatic intracerebral hematomas, tumor bleeding, and bleeding tendencies caused by uremia or liver cirrhosis )
3) Hemorrhage include brain stem.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ohkuma
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address Zaifu-cho 5, Hirosaki-shi, Aomori
TEL 0172-39-5115
Email cerebro@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Katayama
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address Zaifu-cho 5, Hirosaki-shi, Aomori
TEL 0172-39-5115
Homepage URL
Email k.kosuke@hirosaki-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Neurosurgery, Hirosaki University 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
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 弘前大学病院(青森県)
黒石病院(青森県)
青森市民病院(青森県)
十和田市立中央病院(青森県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 19 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
2016 Year 11 Month 01 Day
Last modified on
2016 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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