UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041097
Receipt number R000046925
Scientific Title Assessment of coagulation status in patients undergoing cardiac surgery with cardiopulmonary bypass
Date of disclosure of the study information 2020/07/13
Last modified on 2021/05/07 16:57:56

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Basic information

Public title

Assessment of coagulation status in patients undergoing cardiac surgery with cardiopulmonary bypass

Acronym

Assessment of coagulation status in patients undergoing cardiac surgery with cardiopulmonary bypass

Scientific Title

Assessment of coagulation status in patients undergoing cardiac surgery with cardiopulmonary bypass

Scientific Title:Acronym

Assessment of coagulation status in patients undergoing cardiac surgery with cardiopulmonary bypass

Region

Japan


Condition

Condition

Adult patients undergoing elective cardiac valve surgery with cardiopulmonary bypass

Classification by specialty

Anesthesiology Cardiovascular surgery Operative medicine
Blood transfusion Intensive care medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective is to evaluate the coagulation status (platelet function and deficiency of coagulation factor) by thromboelastography(TEG) during cardiac surgery with cardiopulmonary bypass.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation between parameters of thromboelastography during cardiopulmonary bypass and after cardiopulmonary bypass

Key secondary outcomes

Correlation between parameters of thromboelastography during cardiopulmonary bypass and amounts of postoperative chest tube blood loss


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients undergoing elective cardiac valve surgery with cardiopulmonary bypass

Key exclusion criteria

Patients with
-emergent surgery
-estimated cardiopulmonary bypass time less than 60 minutes
-oral anticoagulants(warfarin, direct thrombin inhibitors, factor Xa inhibitors)

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Yoshinaga

Organization

Jichi Medical University, Saitama Medical Center

Division name

Department of Anesthesiology and Critical Care

Zip code

330-8503

Address

1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, 330-8503, Japan

TEL

0486472111

Email

kyoshinaga@jichi.ac.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Yoshinaga

Organization

Jichi Medical University, Saitama Medical Center

Division name

Department of Anesthesiology and Critical Care

Zip code

330-8503

Address

1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, 330-8503, Japan

TEL

0486472111

Homepage URL


Email

kyoshinaga@jichi.ac.jp


Sponsor or person

Institute

Jichi Medical University, Saitama Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

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

Jichi Medical University, Saitama Medical Center

Address

1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, 330-8503, Japan

Tel

0486472111

Email

kyoshinaga@jichi.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

2020 Year 07 Month 13 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

Enrolling by invitation

Date of protocol fixation

2020 Year 07 Month 13 Day

Date of IRB

2020 Year 07 Month 13 Day

Anticipated trial start date

2020 Year 07 Month 13 Day

Last follow-up date

2022 Year 03 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

2020 Year 07 Month 13 Day

Last modified on

2021 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046925


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name