UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019027 |
|---|---|
| Receipt number | R000022000 |
| Scientific Title | Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2019/06/24 09:23:12 |
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Basic information
Public title
Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Acronym
Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Scientific Title
Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Scientific Title:Acronym
Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Region
| Japan |
Condition
Condition
Massive hemorrhage by trauma, gastrointestinal hemorrhage
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Operative medicine |
| Emergency medicine | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the dosage of the concentrated fibrinogen preparation as supportive treatment for the patients who are expected that a large amount of blood transfusins are required because of massive hemorrage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of total blood tranfusion until hemostasis completion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Term:28 weeks
infusion:Red cell concentrated 10units, ordinary blood transfusion concentrated fibrin preparation 3g
Interventions/Control_2
Term:28 weeks
infusion:Red cell concentrated 10units, ordinary blood transfusion
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
1.The man and woman who are 20 years or older.
2.The patients that doctor recognizes necessity of massive blood transfusin by MTP due to massive hemorrhage by injury and gastrointestinal bleeding.
3.The patients who are conveyed and admitted to emergency and critical care center, without tranferring to the other hospital and Obstetrics,
heart blood vessel sugeryy patient
Key exclusion criteria
1.Pregnant woman
2.Under 20 years old
3.Immunocompromised (state) patients
4.Patients with allegy for blood products
5.Patients who are diagnosed as congenital low fibrinogen blood symptom
6.the patient that informed consent is not provided
7.the patient who is dead during primary care treatment even MTP procedure was exercised or not given the treatment with RCC,FFP and the concentrated fibrin preparation.
8.the patient who cannot perform a blood test after dosage
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Otomo |
Organization
Medical Hospital,Tokyo Medical and Dental University
Division name
Trauma and Acute Critical Care Medical Center
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-3813-6111
otomo.accm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Murata |
Organization
Medical Hospital,Tokyo Medical and Dental University
Division name
Trauma and Acute Critical Care Medical Center
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-3813-6111
Homepage URL
murata.acc@tmd.ac.jp
Sponsor or person
Institute
Trauma and Acute Critical Care Medical Center,Medical Hospital,Tokyo Medical and Dental Universitiy
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Clinical Research Review Board TMDU Medical Hospitale
Address
1-5-45,Yushima, BUnkyo-ward,Tokyo,Japan
Tel
03-3813-6111
03-3813-6111
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
| 2015 | Year | 09 | 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
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2015 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022000
