UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021066 |
|---|---|
| Receipt number | R000023486 |
| Scientific Title | Efficacy of prothrombin complex concentrate in intracranial hemorrhage patients under anticoagulant therapy |
| Date of disclosure of the study information | 2016/02/17 |
| Last modified on | 2018/02/18 09:57:39 |
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Basic information
Public title
Efficacy of prothrombin complex concentrate in intracranial hemorrhage patients under anticoagulant therapy
Acronym
Prothrombin complex concentratein intracranial hemorrhage patients
Scientific Title
Efficacy of prothrombin complex concentrate in intracranial hemorrhage patients under anticoagulant therapy
Scientific Title:Acronym
Prothrombin complex concentratein intracranial hemorrhage patients
Region
| Japan |
Condition
Condition
Intracranial hemorrhage
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of prothrombin complex concentrate in intracranial hemorrhage patients under anticoagulant therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PT-INR value at 30 minutes after infusion of prothrombin complex concentrate
Key secondary outcomes
expansion of hematoma
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous administration of Prothrombin complex concentrate (500-1000 unit) and Vitamin K 10mg
A dose of PCC
PT-INR 2.0-2.9; 500 unit
PT-INR 3.0>; 1000 unit
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Intracranial hemorrhage within 24 hours after onset
and
INR value more than 2.0 under warfarin therapy
Key exclusion criteria
Patients with contraindication for complex concentrate and Vitamin K
Patients with fatal intracranial hemorrhage
Inappropriate patients for this study judged by the physicians.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Mizuno |
Organization
Kyoto Prefectural University of Medicine
Division name
Neurology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5793
mizuno@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Ohara |
Organization
Kyoto Prefectural University of Medicine
Division name
Neurology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5793
Homepage URL
ohatomo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University 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
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
| 2016 | Year | 02 | Month | 17 | 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
| 2016 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | 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
| 2016 | Year | 02 | Month | 17 | Day |
Last modified on
| 2018 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023486
