UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024675 |
|---|---|
| Receipt number | 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 | 2021/05/25 20:02:27 |
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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 | 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
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
k.kosuke@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027934
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| Registered date | File name |
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