UMIN-CTR Clinical Trial

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 Hiroki Middle name Last name Ohkuma
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	036-8562
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 Kosuke Middle name Last name Katayama
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	036-8562
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	crb-hirosaki
Address	Zaifu-cho 5, Hirosaki-shi, Aomori, Japan
Tel	+81-172-39-5362
Email	crb-hirosaki@hirosaki-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	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	2016 Year 10 Month 19 Day
Anticipated trial start date	2016 Year 10 Month 19 Day
Last follow-up date	2021 Year 06 Month 30 Day
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	2021 Year 05 Month 25 Day

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