UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017286
Receipt number R000020005
Scientific Title The examination of blood transfusion by guiding blood coagulation and platelet function
Date of disclosure of the study information 2015/04/28
Last modified on 2017/04/28 18:25:18

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Basic information

Public title

The examination of blood transfusion by guiding blood coagulation and platelet function

Acronym

The examination of blood transfusion by guiding blood coagulation and platelet function

Scientific Title

The examination of blood transfusion by guiding blood coagulation and platelet function

Scientific Title:Acronym

The examination of blood transfusion by guiding blood coagulation and platelet function

Region

Japan


Condition

Condition

the patients scheduled to open heart surgery

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In cardiac surgery, efficacy of Point-of-Care (POC) monitoring in the management of coagulopathy has been noticed. In the STS/SCA blood conservation clinical practice guideline, transfusion algorithms including POC monitoring is recommended. we retrospectively investigated the effects of Sonoclot-guided coagulopathy management on the amount of intraoperative transfusion in cardiac surgery under cardiopulmonary bypass.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The amount of intraoperative transfusion after finished the cardiopulmonary bypass

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Sonoclot which evaluated blood coagulation and platelet function was used during operation. Observation was continued to the first day after operation

Interventions/Control_2

Control group was not used sonoclot. Observation was continued to the first day after operation

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients whom scheduled or underwent cardiac surgery under cardiopulmonary bypass

Key exclusion criteria

Patients whom were unconscious or refused participation of the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsutaka Edanaga

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Email

edanaka@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Takeda

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Homepage URL


Email

hiroshi.takeda@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Sapporo Medical University School of Medicine

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 04 Month 28 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2014 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 27 Day

Last modified on

2017 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020005


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name