UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus for patients using cardiopulmonary bypass
Acronym	The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus
Scientific Title	The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus for patients using cardiopulmonary bypass
Scientific Title:Acronym	The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus for patients using cardiopulmonary bypass
Region	Japan

Condition
Condition	Patients who receive cardiac surgery
Classification by specialty	Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Use quantra to determine if it accurately predicts fibrinogen levels and platelet counts as measured by central testing
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparing fibrinogen level and platelet counts 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	Not applicable
Gender	Male and Female
Key inclusion criteria	cases of cardiac surgery using CPB
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	1st name shingo Middle name Last name kawashima
Organization	Hamamatsu Medical University of School
Division name	Department of Anesthesiology and Intensive Care
Zip code	4313192
Address	1-20-1 Handayama Higashi-ku Hamamatsu city
TEL	053-435-2286
Email	shingogo@hama-med.ac.jp

Public contact
Name of contact person	1st name shingo Middle name Last name kawashima
Organization	Hamamatsu Medical University of School
Division name	Department of Anesthesiology and Intensive Care
Zip code	Hamamatsu Medical University of School
Address	1-20-1 Handayama Higashi-ku Hamamatsu city
TEL	053-435-2286
Homepage URL
Email	shingogo@hama-med.ac.jp

Sponsor
Institute	Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine
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	Hamamatsu University School of Medicine
Address	1-20-1 Handayama Higashi-ku Hamamatsu city
Tel	0534352111
Email	shingogo@hama-med.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	2022 Year 04 Month 20 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	2022 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date	2022 Year 04 Month 20 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 04 Month 20 Day
Last modified on	2022 Year 04 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054218