UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010294 |
|---|---|
| Receipt number | R000012050 |
| Scientific Title | Efficacy and safety of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions: prospective single arm clinical trial |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/09/10 23:09:04 |
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Basic information
Public title
Efficacy and safety of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions: prospective single arm clinical trial
Acronym
Pilot study of early fibrinogen concentrate substitution therapy for severe trauma patients
Scientific Title
Efficacy and safety of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions: prospective single arm clinical trial
Scientific Title:Acronym
Pilot study of early fibrinogen concentrate substitution therapy for severe trauma patients
Region
| Japan |
Condition
Condition
severe trauma
Classification by specialty
| Surgery in general | Orthopedics | Neurosurgery |
| Emergency medicine | Blood transfusion | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To decide adequate dose of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
the amount of blood transfusion for 24 hours after the hospital arriving
mortality for 72 hours after the hospital arriving
morbidity of venous thromboembolism during the hospital stay
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
freeze-dried human fibrinogen
Fibrinogen HT i.v. 1g - BENESIS
only the receiving injury day
dosage 2g or 3g/time
maximum of two times
Hemorrhagic trauma patients, whose serum fibrinogen concentration on admission is lower than 150mg/dl, are included in the trial. Freeze-dried human fibrinogen concentrate is administered once or twice within 24 hours of the injury. If the initial concentration is higher than 100mg/dl, 2g of the Fibrinogen is administered, else 3g is administered. Following the administration, the concentration is measured again. If the measurement is still lower than 150mg/dl, the second dose of Fibrinogen is administered according to the same criteria used to determine the initial dose. The concentration is measured again following the second administration.
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
| 12 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
arrive at hospital within 3 hours after accident
shock or pre-shock
serum fibrinogen <=150mg/dl
Key exclusion criteria
(1)history of venous thromboembolism
(2)thrombotic diathesis (such as antithrombin deficiency,Protein S/C deficiency,antiphospholipid antibody syndrome)
(3)Agreement acquisition is impossible from the patient and the family.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Inokuchi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
Kawagoe-shi Kamoda 1981, JAPAN
TEL
0492283597
inok_k@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Inokuchi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
Kawagoe-shi Kamoda 1981, JAPAN
TEL
0492283597
Homepage URL
inok_k@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical 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
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
埼玉医科大学総合医療センター （埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | 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 | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2014 | 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
| 2013 | Year | 03 | Month | 22 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012050
