UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009481
Receipt number R000011132
Scientific Title Autologous cell salvage can induce coagulopathy in cardiopulmonary bypass surgery: an ex-vivo study
Date of disclosure of the study information 2012/12/05
Last modified on 2012/12/05 15:00:22

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Basic information

Public title

Autologous cell salvage can induce coagulopathy in cardiopulmonary bypass surgery: an ex-vivo study

Acronym

CS coagulopathy

Scientific Title

Autologous cell salvage can induce coagulopathy in cardiopulmonary bypass surgery: an ex-vivo study

Scientific Title:Acronym

CS coagulopathy

Region

Japan


Condition

Condition

cardiopulmonary bypass surgery

Classification by specialty

Vascular surgery Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate that autologous cell salvage can induce coagulopathy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

coagulopathy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

postoperative administration of autotransfusion (+)

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients undergoing cardiopulmonary bypass
Patients from whom informed consent was obtained

Key exclusion criteria

Congenital disease
Patient undergoing PCPS
Doctor's decision not to register to this regimen

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Ogasawara

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Thoracic and Cardiovascular Surgery

Zip code


Address

5 Zaifucho, Hirosaki, Aomori

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Thoracic and Cardiovascular Surgery

Zip code


Address

5 Zaifucho, Hirosaki, Aomori

TEL


Homepage URL


Email



Sponsor or person

Institute

Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

2012 Year 12 Month 05 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

2012 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 01 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

2012 Year 12 Month 05 Day

Last modified on

2012 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011132


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name