UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030812 |
|---|---|
| Receipt number | R000035180 |
| Scientific Title | Efficacy of Lyophilized Human Prothrombin Complex Concentrate on acute patients with hemorrhage: a single arm phase II study |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2021/01/17 17:36:06 |
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Basic information
Public title
Efficacy of Lyophilized Human Prothrombin Complex Concentrate on acute patients with hemorrhage: a single arm phase II study
Acronym
Lyophilized Human Prothrombin Complex Concentrate on acute patients: a single arm phase II study
Scientific Title
Efficacy of Lyophilized Human Prothrombin Complex Concentrate on acute patients with hemorrhage: a single arm phase II study
Scientific Title:Acronym
Lyophilized Human Prothrombin Complex Concentrate on acute patients: a single arm phase II study
Region
| Japan |
Condition
Condition
Severe trauma patients with cerebral hemorrhage, those who were admitted to the Advanced Critical Care and Emergency Center and had less than 2 in PT-INR
Classification by specialty
| Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an efficacy of Lyophilized Human Prothrombin Complex Concentrate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in hemorrhage between the beginning of medication and hospital discharge
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) Once during a hospital stay
2) Amount
PT-INR >=2, <4: body weight<=100kg = 25IU/kg, body weight>100kg = 2500IU
PT-INR >=4, <=6: body weight<=100kg = 35IU/kg, body weight>100kg = 3500IU
PT-INR >6: body weight<=100kg = 50IU/kg, body weight>100kg = 5000IU
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Severe trauma patients with cerebral hemorrhage, those who were admitted to the Advanced Critical Care and Emergency Center and had less than 2 in PT-INR
Key exclusion criteria
1) Severe trauma patients with cerebral hemorrhage, those who were admitted to the Advanced Critical Care and Emergency Center and had greater than or equal to 2 in PT-INR
2) Patients, those who were determined by a physician as not-adequate to include the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takeuchi |
Organization
Yokohama City University Medical Center
Division name
Advanced Critical Care and Emergency Center
Zip code
232-0024
Address
4-57 Urafunecho, Minamiku, Yokohama, Kanagawa
TEL
045-261-5656
itake@myad.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kawasaki |
Organization
Yokohama City University Medical Center
Division name
Advanced Critical Care and Emergency Center
Zip code
232-0024
Address
4-57 Urafunecho, Minamiku, Yokohama, Kanagawa
TEL
045-261-5656
Homepage URL
tks59jn@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Advanced Critical Care and Emergency Center, Yokohama City University Medical Center
Address
4-57 Urafunecho, Minamiku, Yokohama City, Kanagawa
Tel
045-261-5656
takeru-a@umin.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 15 | 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
0
Results
Continuing patient recruiting
Results date posted
| 2020 | Year | 01 | Month | 17 | Day |
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035180
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
