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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034731
Receipt No. R000039584
Official scientific title of the study 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 2018/12/07

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Basic information
Official scientific title of the study Clinical evaluation of TEG6s PlateletMapping assay during cardiopulmonary bypass : A prospective observational study
Title of the study (Brief title) 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 Tokujiro Uchida
Organization Tokyo Medical and Dental University Graduate School of Medicine
Division name Department of Anesthesiology
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 Yudai Yamamoto
Organization Tokyo Medical and Dental University Graduate School of Medicine
Division name Department of Anesthesiology
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
Co-sponsor
Name of secondary funder(s)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 30 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.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
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