UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041598 |
|---|---|
| Receipt number | R000047487 |
| Scientific Title | Emergency administration of fibrinogen concentrate for hemorrhage: a protocol for systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2023/01/29 13:24:50 |
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Basic information
Public title
Emergency administration of fibrinogen concentrate for hemorrhage: a protocol for systematic review and meta-analysis
Acronym
Emergency administration of fibrinogen concentrate for hemorrhage: a protocol for systematic review and meta-analysis
Scientific Title
Emergency administration of fibrinogen concentrate for hemorrhage: a protocol for systematic review and meta-analysis
Scientific Title:Acronym
Emergency administration of fibrinogen concentrate for hemorrhage: a protocol for systematic review and meta-analysis
Region
| Japan |
Condition
Condition
trauma, gastrointesitinal haemorrhage, surgery, postpartum
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Obstetrics and Gynecology |
| Orthopedics | Radiology | Anesthesiology |
| Cardiovascular surgery | Operative medicine | Emergency medicine |
| Blood transfusion | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to clarify the efficacy of emergent administration of fibrinogen concentrate compared with other established transfusion strategy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome will be in-hospital
Key secondary outcomes
Secondary outcome will be the quantity of the transfusions within 24hours, blood loss within 24hours, thrombotic events (i.e. deep venous thrombosis, pulmonary embolization, myocardial infarction and stroke), multiple organ failure, or acute organ dysfunction (i.e. acute kidney injury etc.) length of intensive care unit stay and length of hospital stay.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
We include the randomized controlled trials that the intervention for severe hemorrhagic diseases by fibrinogen concentrate.
Key exclusion criteria
Observational studies
Hemorrhage in the elective surgery
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Itagaki |
Organization
Sapporo city general hospital
Division name
Emergency and critical care center
Zip code
060-8604
Address
Nishi 13, kita11, chu-o-ku, Sapporo city, Hokkaido, Japan
TEL
011-726-2211
koaraninaritaizo@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Itagaki |
Organization
Sapporo city general hospital
Division name
Emergency and critical care center
Zip code
060-8604
Address
Nishi 13, kita11, chu-o-ku, Sapporo city, Hokkaido, Japan
TEL
011-726-2211
Homepage URL
koaraninaritaizo@gmail.com
Sponsor or person
Institute
Sapporo city general hospital
Emergency and critical care center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo city general hospital
Address
kita11 nishi13, chu-o-ku, Sapporo, Hokkaido, Japan
Tel
+81-11-726-2211
koaraninaritaizo@gmail.com
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
市立札幌病院 / Sapporo city general hospital
北海道大学病院 / Hokkaido University Hospital
大阪医科大学 / Osaka medical college
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
https://journals.lww.com/md-journal/Fulltext/2021/03120/Emergency_administration_of_fibrinogen_conce
Publication of results
Partially published
Result
URL related to results and publications
https://www.researchsquare.com/article/rs-2480451/v1
Number of participants that the trial has enrolled
4
Results
Nine RCTs in the qualitative synthesis with a total of 701 patients were included.
There was no reduction in the use of red blood cells (RBC) transfusion in the first 24 h after admission with FC treatment.
However, the use of fresh frozen plasma (FFP) transfusion significantly increased in the first 24 h after admission with FC treatment .
Results date posted
| 2023 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Severe trauma patients
Participant flow
Not applicable.
Adverse events
None.
Outcome measures
The primary outcome measure was all-cause in-hospital mortality. Secondary outcome measures included the volume of transfused blood within the first 24 h, blood loss within the first 24 h, thrombotic events (i.e., deep venous thromboses, pulmonary embolization, myocardial infarctions, strokes), multiple organ failure, length of intensive care unit (ICU) stay, and length of hospital stay.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
We aim to clarify the efficacy and the safety of emergent administration of fibrinogen concentrate compared with other established transfusion strategy by conducting a systematic review and meta-analysis.
Authors
Yuki Itagaki, MD,
1 Emergency and Critical Care Centre, Sapporo City General Hospital, Sapporo, Hokkaido, Japan
Mineji Hayakawa, MD, PhD
2 Department of Emergency Medicine, Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Yuki Takahashia, MD
1 Emergency and Critical Care Centre, Sapporo City General Hospital, Sapporo, Hokkaido, Japan
Kazuma Yamakawa, MD, PhD
3 Department of Emergency Medicine, Osaka Medical College, Osaka, Japan
Author contributions
Kazuma Yamasaka(KY) and Mineji Hayakawa (MH) were guarantors and contributed to the conception of the study. The manuscript protocol was drafted by Yuki Itagaki (YI) and was revised by KY and MH. The search strategy was developed by all of the authors and will be performed by YI and MH. YI and Yuki Takahashi (YT) will independently extract data from the included studies, assess the risk of bias and complete the data synthesis. KY will arbitrate in cases of disagreement and ensure the absence of errors. All authors approved the publication of this protocol.
Funding
Funding information is not available.
Conflict of interest
The authors of this work have nothing to disclose.
Management information
Registered date
| 2020 | Year | 08 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047487
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/02/09 | UMIN_Albumin.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
