UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019726
Receipt number R000022782
Scientific Title Coaglation and fibrinolytic function in use of intraoperative blood salvage for cardiovasucular surgery
Date of disclosure of the study information 2015/11/10
Last modified on 2018/05/31 05:30:59

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Basic information

Public title

Coaglation and fibrinolytic function in use of intraoperative blood salvage for cardiovasucular surgery

Acronym

Blood salvage and coagulation function

Scientific Title

Coaglation and fibrinolytic function in use of intraoperative blood salvage for cardiovasucular surgery

Scientific Title:Acronym

Blood salvage and coagulation function

Region

Japan


Condition

Condition

patients undergoing cardiovascular surgeries

Classification by specialty

Anesthesiology Cardiovascular surgery Blood transfusion

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore mechanisms of coagulation dysfunction in blood salvage in vitro preparation

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fibtem MCF (maximum Clot Firmness) obtained from thoromboelastometry

Key secondary outcomes

Extem MCF and CT obtained form thoronboelastometry


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients undergoing scheduled cardiovascular surgeries
2. Patients prepared for use of blood slvage

Key exclusion criteria

1. Patients undergoing emergency surgeries
2. Patients with hematologic diseases
3. Patients with contraindication for use of heparin

Target sample size

55


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Son Kyongsuk

Organization

Chiba University Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-8-1 Inohana-cho, Chuo-ku, Chiba

TEL

043-222-7171

Email

kyong0203suk@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Son Kyongsuk

Organization

Chiba University Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-8-1 Inohana-cho, Chuo-ku, Chiba

TEL

043-222-7171

Homepage URL


Email

kyong0203suk@yahoo.co.jp


Sponsor or person

Institute

Department of Anesthesiology, Chiba University Hosppital

Institute

Department

Personal name



Funding Source

Organization

Institutional

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 10 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

Completed

Date of protocol fixation

2015 Year 11 Month 09 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

By using thoromboelastometry, we plan to exlore presence of does dependence of coagulation dysfunction and determine independent factors for the coagulation dysfunction. When the investigators work in the operating room, the first 65 patients fulfilling the inclusion criteria will be studied during the study period.


Management information

Registered date

2015 Year 11 Month 10 Day

Last modified on

2018 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022782


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name