UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040786
Receipt number R000046575
Scientific Title Analysis of the dynamic change of platelet before and after cardiac surgery
Date of disclosure of the study information 2020/06/16
Last modified on 2020/06/16 16:17:58

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Basic information

Public title

The change of platelet by cardiac surgery

Acronym

The change of platelet by cardiac surgery

Scientific Title

Analysis of the dynamic change of platelet before and after cardiac surgery

Scientific Title:Acronym

Analysis of the dynamic change of platelet before and after cardiac surgery

Region

Japan


Condition

Condition

cardiac diseases

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We analyze the chronological change of platelet proteins, peptides, and small RNAs before and after cardiac surgery.

Basic objectives2

Others

Basic objectives -Others

We identify the platelet proteins, peptides, and small RNAs altered by cardiac surgery.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Vascular endothelial growth factor (VEGF) in serum: From just before cardiac surgery to one month after surgery.

Key secondary outcomes

MicroRNAs in serum and platelets.
IL-6 and thrombopoietin (TPO) in serum.C-reactive protein (CRP) and Brain natriuretic peptide (BNP) in serum.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with cardiac surgery.

Key exclusion criteria

Patients with dialysis

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yutaka
Middle name
Last name Imoto

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Department of Cardiovascular and Gastroenterological Surgery

Zip code

890-8520

Address

8-35-1 Sakuragaoka, Kagoshima

TEL

099-275-5368

Email

imoto@m3.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Teruto
Middle name
Last name Hashiguchi

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Department of Laboratory and Vascular Medicine

Zip code

890-8520

Address

8-35-1 Sakuragaoka, Kagoshima

TEL

099-275-5437

Homepage URL


Email

terutoha@m3.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kagoshima Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The research ethics committees of Kagoshima University Hospital

Address

8-35-1 Sakuragaoka, Kagoshima

Tel

099-275-6692

Email

crmc@m2.kufm.kagoshima-u.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 06 Month 16 Day


Related information

URL releasing protocol

https://com4.kufm.kagoshima-u.ac.jp/department/015-2/015-6/

Publication of results

Unpublished


Result

URL related to results and publications

N/A

Number of participants that the trial has enrolled

98

Results

Elevation of intra-platelet VEGF-A and miR-126 were observed after cardiac surgery.

Results date posted

2020 Year 06 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Male patients shared 95%. Patients with hypertension, or diabetes, or peripheral artery disease, represented 85%, 50%, and 12%, respectively.

Participant flow

All participants attended this study after administration of Kagoshima University Hospital and providing written informed consents.

Adverse events

N/A

Outcome measures

IL-6 and TPO in serum, miR-126 and VEGF in serum and platelet, were measured. The data from the routine blood tests, complete blood counts and biochemical blood test, were referred.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 12 Month 27 Day

Date of IRB

2013 Year 12 Month 27 Day

Anticipated trial start date

2014 Year 01 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ninety eight patients were registered and analyzed.


Management information

Registered date

2020 Year 06 Month 16 Day

Last modified on

2020 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046575


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name