UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of hyperglycemia in patients with acute intracerebral hemorrhage: A Randomised Pilot Study.
Title of the study (Brief title)	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	Takashi Shimioyama
Organization	Kawasaki Medical School
Division name	Department of Stroke Medicine
Address	557 Matsushima, Kurashiki City, Okayama
TEL
Email

Public contact
Name of contact person
Organization	Kawasaki Medical School
Division name	Department of Stroke Medicine
Address	557 Matsushima, Kurashiki City, Okayama
TEL
Homepage URL
Email

Sponsor
Institute	Department of Stroke Medicine, Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 02 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011806