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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042771
Receipt No. 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

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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
Email 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
Email e6580@cc.saga-u.ac.jp

Sponsor
Institute Saga University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048818

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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