UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010079 |
|---|---|
| Receipt number | R000011806 |
| Scientific Title | Treatment of hyperglycemia in patients with acute intracerebral hemorrhage: A Randomised Pilot Study. |
| Date of disclosure of the study information | 2013/02/19 |
| Last modified on | 2019/03/02 00:43:55 |
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Basic information
Public title
Treatment of hyperglycemia in patients with acute intracerebral hemorrhage: A Randomised Pilot Study.
Acronym
Treatment of hyperglycemia in patients with acute intracerebral hemorrhage.
Scientific Title
Treatment of hyperglycemia in patients with acute intracerebral hemorrhage: A Randomised Pilot Study.
Scientific Title:Acronym
Treatment of hyperglycemia in patients with acute intracerebral hemorrhage.
Region
| Japan |
Condition
Condition
intra-cerebral hemorrhage, diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the safety and feasibility of usual hyperglycemia correction with insulin therapy compared with loose care during diabetic acute intra-cerebral hemorrhage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemorrhagic volume, neurological deterioration, and complication in acute phase and mRS at 90 days.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Usual insulin therapy in the management of glycemic control
Interventions/Control_2
Loose insulin therapy in the management of glycemic control
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with acute intra-cerebral hemorrhage within 24 h onset
2)Prior diabetes or admission glucose >200mg/dl
Key exclusion criteria
1)age <18 years
2)pregnancy
3)diabetic ketoacidosis
4)any premorbid condition that might have compromised evaluation and treatment (e.g. end stage of cancer)
5)traumatic intra-cerebral hemorrhage, subarachnoid hemorrhage, and vascular anomaly.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Shimioyama |
Organization
Kawasaki Medical School
Division name
Department of Stroke Medicine
Zip code
Address
557 Matsushima, Kurashiki City, Okayama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kawasaki Medical School
Division name
Department of Stroke Medicine
Zip code
Address
557 Matsushima, Kurashiki City, Okayama
TEL
Homepage URL
Sponsor or person
Institute
Department of Stroke Medicine, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2013 | Year | 02 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | 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
| 2013 | Year | 02 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011806
