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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010294
Receipt No. 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

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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
Email 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
Email inok_k@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012050

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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