UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022666 |
|---|---|
| Receipt number | R000026124 |
| Scientific Title | Application of fibrinogen concentrate (Fibrinogen HT) to uncontrollable massive bleeding |
| Date of disclosure of the study information | 2016/06/08 |
| Last modified on | 2019/06/11 20:12:31 |
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Basic information
Public title
Application of fibrinogen concentrate (Fibrinogen HT) to uncontrollable massive bleeding
Acronym
Application of Fibrinogen HT to massive bleeding
Scientific Title
Application of fibrinogen concentrate (Fibrinogen HT) to uncontrollable massive bleeding
Scientific Title:Acronym
Application of Fibrinogen HT to massive bleeding
Region
| Japan |
Condition
Condition
Massive bleeding during
1)Pregnancy and delivery
2)Cardiovascular surgery
3)Gastrointestinal (including hepato-biliary-pancreatic) surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Cardiovascular surgery | Blood transfusion |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate that fibrinogen concentrate (Fibrinogen HT) can improve uncontrollable massive bleeding during pregnancy, delivery, caridiovascular surgery and gastorointestinal (including hepato-biliary-pancreatic) surgery instead of using fresh allogenic blood obtained in the hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Avoidance rate of using fresh allogenic blood obtained in the hospital to uncontrollable massive bleeding
Key secondary outcomes
Survival rate
Fibrinogen value before and after the usage of fibrinogen concentrate
Blood loss
Blood product usage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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 Fibrinogen HT(3g) in ten minuites to uncontrollable massive bleeding whose fibrinogen value is under 100mg/dl. Historical controls are number of patients under same condition who were treated with fresh allogenic blood obtained in the hospital.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Massive bleeding during pregnancy or delivery, increased bleeding (>4000ml) during cardiovascular surgery, or gastrointestinal (including hepato-biliary-pnacreatic) surgery whose fibrinogen value is lower than 100mg/dl or suspected to be lower than 100mg/dl in case of emergency.
Key exclusion criteria
Patient (or the patient's family) who did not give informed consent.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Furukawa |
Organization
Kagoshima University Hospital
Division name
Division of blood transfusion medicine and cell therapy
Zip code
890-8520
Address
8-35-1 Sakuragaoka Kagoshima, 890-8520, Japan
TEL
099-275-5635
furukawy@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Furukawa |
Organization
Kagoshima University Hospital
Division name
Division of blood transfusion medicine and cell therapy
Zip code
890-8520
Address
8-35-1 Sakuragaoka Kagoshima, 890-8520, Japan
TEL
099-275-5635
Homepage URL
furukawy@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital,
Division of blood transfusion medicine and cell therapy
Institute
Department
Personal name
Funding Source
Organization
None
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
Kagoshima University Hospital,
Address
8-35-1 Sakuragaoka Kagoshima, 890-8520, Japan
Tel
099-275-6692
kufsyomu@kuas.kagoshima-u.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
| 2016 | Year | 06 | Month | 08 | 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
26
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 08 | Day |
Last modified on
| 2019 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026124
