UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of cold platelet for trauma and cardiovascular surgery. Prospective study for massive bleeding patients using point of care coagulation test by ex vivo.
Acronym	Effectiveness of cold platelet for trauma and cardiovascular surgery
Scientific Title	Effectiveness of cold platelet for trauma and cardiovascular surgery
Scientific Title:Acronym	Effectiveness of cold platelet for trauma and cardiovascular surgery
Region	Japan

Condition
Condition	trauma, cardiovascular surgery
Classification by specialty	Vascular surgery Anesthesiology Cardiovascular surgery Emergency medicine Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	As a preliminary study to determine whether cold platelets are clinically practical and whether these platelets concentrates are effective for massive bleeding cases including trauma and cardiovascular surgery. We plan to compare two types of platelet concentrates stored room temperature or fridge (4 celcius degree).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparing platelet function using point of care viscoelastic device and the other tests.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Trauma or cardiovascular cases predicted to transfuse platelet concentrate.
Key exclusion criteria	Patients without informed consent
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Mitsuharu Middle name Last name Kodaka
Organization	Tokyo women's medical university
Division name	Medical center east, anesthesiology
Zip code	116-8567
Address	2-1-10 Nishiogu Arakawa-ku, 116-8567 Tokyo
TEL	03-3810-1111
Email	kmkodaka@cb3.so-net.ne.jp

Public contact
Name of contact person	1st name Mitsuharu Middle name Last name Kodaka
Organization	Tokyo women's medical university
Division name	Medical center east, anesthesiology
Zip code	116-8567
Address	2-1-10 Nishiogu Arakawa-ku, 116-8567 Tokyo
TEL	03-3810-1111
Homepage URL
Email	kmkodaka@cb3.so-net.ne.jp

Sponsor
Institute	Tokyo women's medical university
Institute
Department

Funding Source
Organization	Ministry of education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Tokyo women's medical university
Address	8-1 Kawada-cho Sinjyuku-ku Tokyo
Tel	03-3353-8111
Email	http://www.twmu.ac.jp/RINRI/mokuteki.html

Secondary IDs
Secondary IDs	YES
Study ID_1	2020-38
Org. issuing International ID_1	IRB of TWMU
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 18 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	20
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	No longer recruiting
Date of protocol fixation	2020 Year 12 Month 26 Day
Date of IRB	2021 Year 02 Month 02 Day
Anticipated trial start date	2021 Year 01 Month 18 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Comparing platelet function using point of care viscoelastic device and the other tests.

Management information
Registered date	2021 Year 01 Month 17 Day
Last modified on	2021 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049129