UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009836
Receipt No. R000011528
Scientific Title the efficacy of infusions of clotting factor concentrate on emergency reversal of anticoagulation after intracerebral hemorrhage
Date of disclosure of the study information 2013/01/25
Last modified on 2017/11/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title the efficacy of infusions of clotting factor concentrate on emergency reversal of anticoagulation after intracerebral hemorrhage
Acronym clotting factor concentrate on emergency reversal of anticoagulation after intracerebral hemorrhage
Scientific Title the efficacy of infusions of clotting factor concentrate on emergency reversal of anticoagulation after intracerebral hemorrhage
Scientific Title:Acronym clotting factor concentrate on emergency reversal of anticoagulation after intracerebral hemorrhage
Region
Japan

Condition
Condition intracerebral hemorrhage
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the efficacy of infusions of clotting factor concentrate on emergency reversal of anticoagulation after intracerebral hemorrhage
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes modified Rankin score at 3 months
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 clotting factor concentrate(IX factor)
Interventions/Control_2
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
40 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria intracerebral hemorrhage on anticoagulation within 24 hours after onset
Key exclusion criteria INR<1.3 on admission
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Uemura
Organization Kawasaki Medical School
Division name Stroke Medicine
Zip code
Address 577 Matsushima, Kurashiki City
TEL 086-462-1111
Email uemuratrail@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Uemura
Organization Kawasaki Medical School
Division name Stroke Medicine
Zip code
Address Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email uemuratrail@yahoo.co.jp

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

Funding Source
Organization Department of Stroke Medicine, Kawasaki Medical School
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

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 25 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 01 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 25 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
2017 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 22 Day
Last modified on
2017 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011528

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.