UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042771 |
|---|---|
| Receipt number | R000048818 |
| Scientific Title | Survey of the use of cryoprecipitate and cryoprecipitate-depleted plasma in patients with massive bleeding |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2020/12/16 18:52:15 |
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Basic information
Public title
Survey of the use of cryoprecipitate and cryoprecipitate-depleted plasma in patients with massive bleeding
Acronym
Survey of the use of cryoprecipitate and cryoprecipitate-depleted plasma in patients with massive bleeding
Scientific Title
Survey of the use of cryoprecipitate and cryoprecipitate-depleted plasma in patients with massive bleeding
Scientific Title:Acronym
Survey of the use of cryoprecipitate and cryoprecipitate-depleted plasma in patients with massive bleeding
Region
| Japan |
Condition
Condition
Patients with massive bleeding in the perioperative period or in the emergency department
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) We will investigate the use of cryoprecipitate and oligocryo in our hospital, (2) We will compare the safety and usefulness of oligocryo use with non-use in terms of "reduction of postoperative blood loss", "perioperative use of blood products and albumin products", "mortality rate", and "presence of transfusion-related complications".
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) To investigate the degree of correlation between the amount of oligocryoprecipitate used and the amount of perioperative blood loss and the amount of blood products used in the perioperative period.
2) To investigate the correlation between oligocryoprecipitate use and postoperative albumin use.
Key secondary outcomes
1) To determine the correlation between the amount of cryoprecipitate used and in-hospital mortality and transfusion-related complications
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients in whom cryoprecipitate was used
2) Patients who will undergo the above surgery under general anesthesia
3) Age: 18 years and older
4) Gender: Any gender
5) Inpatient/outpatient: Inpatient
Key exclusion criteria
1.Patients who have difficulty communicating due to dementia, mental illness, etc
2.Patients who are judged by the principal investigator and sub-investigators to have problems with participation in the study
3.Patients who have expressed their refusal to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Tanigawa |
Organization
Saga University Hospital
Division name
Anesthesiology and Critical Care Medicins
Zip code
849-8501
Address
5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
TEL
0952343370
e6580@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Tanigawa |
Organization
Saga University Hospital
Division name
Anesthesiology and Critical Care Medicins
Zip code
849-8501
Address
5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
TEL
0952343370
Homepage URL
e6580@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saga University Hospital
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
Saga University Hospital
Address
5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
Tel
0952343370
e6580@cc.saga-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
| 2021 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2007 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2020 | Year | 12 | Month | 16 | Day |
Last modified on
| 2020 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048818
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
