UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of TEG6s PlateletMapping assay during cardiopulmonary bypass : A prospective observational study
Acronym	Clinical evaluation of TEG6s PlateletMapping assay during cardiopulmonary bypass.
Scientific Title	Clinical evaluation of TEG6s PlateletMapping assay during cardiopulmonary bypass : A prospective observational study
Scientific Title:Acronym	Clinical evaluation of TEG6s PlateletMapping assay during cardiopulmonary bypass.
Region	Japan

Condition
Condition	1. Patients undergoing cardiovascular surgery using cardiopulmonary bypass
Classification by specialty	Anesthesiology Cardiovascular surgery Blood transfusion Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether Platelet Mapping ADP be able to indicate FFP transfusion during CPB 2) To evaluate whether Platelet Mapping ADP be able to indicate platelet transfusion after CPB
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Correlation between plasma fibrinogen concentration and MAFibrin in Platelet Mapping assay. 2. Correlation between platelet count and MAADP, MAThrombin
Key secondary outcomes	1) Correlation between platelet inhibition (MAThrombin - MAADP) and medication history, duration of cardiopulmonary bypass 2) Comparing the data from the samples drawn at the end of the aortic cross clamping with those from the samples drawn after protamine administration

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
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient undergoing an elective cardiovascular surgery using cardiopulmonary bypass in Tokyo Medical and Dental University
Key exclusion criteria	Patients who refuse obtainment of informed consent
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tokujiro Uchida
Organization	Tokyo Medical and Dental University Graduate School of Medicine
Division name	Department of Anesthesiology
Zip code
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5325
Email	pocanalysis-group@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yudai Yamamoto
Organization	Tokyo Medical and Dental University Graduate School of Medicine
Division name	Department of Anesthesiology
Zip code
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5325
Homepage URL
Email	pocanalysis-group@umin.ac.jp

Sponsor
Institute	Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Haemonetics Japan GK
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
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IRB Contact (For public release)
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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	東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information	2018 Year 12 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
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Baseline Characteristics
Participant flow
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IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 11 Month 30 Day
Date of IRB	2019 Year 03 Month 19 Day
Anticipated trial start date	2019 Year 03 Month 19 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Data sampling: Clinical information listed below is recorded from patient's clinical record by POD2.Preoperative data: age, gender, height, body weight, diagnosis, planned operation, preoperative laboratory data (CBC, Chemistry, Coagulation, physiological exam), medication list Surgical data: duration of anesthesia, duration of surgery, duration of cardiopulmonary bypass, duration of aortic cross clamping, blood loss, urine output, transfusion, intraoperative arterial blood gas analysis. Postoperative data: blood loss in the first 24hr, postoperative transfusion, laboratory data on POD1 and POD2, postoperative sternotomy for massive bleeding 2) Blood sampling and measurement Blood (10mL) is sampled via arterial line at the time point listed below. (1) Baseline: soon after the anesthetic induction (2) During cardiopulmonary bypass: at the end of aortic cross clamping (3) After the protamine administration After the sampling, blood sample is divided into the tube for coagulation, CBC, and TEG6s platelet mapping and plasma sampling. Plasma samples are stored at -80 degree Celsius. CBC, PT, APTT, and fibrinogen concentration are measured, and Platelet Mapping assay is performed.

Management information
Registered date	2018 Year 11 Month 01 Day
Last modified on	2020 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039584