UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034731
Receipt number R000039584
Scientific Title Clinical evaluation of TEG6s PlateletMapping assay during cardiopulmonary bypass : A prospective observational study
Date of disclosure of the study information 2018/12/01
Last modified on 2020/09/18 11:10:40

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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


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

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 or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

Haemonetics Japan GK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039584


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name