UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012245
Receipt number R000013113
Scientific Title Functional evaluation of neutrophil of patients at high risk for infection treated with monocyte/ neutrophil apheresis
Date of disclosure of the study information 2013/11/08
Last modified on 2014/11/27 20:42:46

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Basic information

Public title

Functional evaluation of neutrophil of patients at high risk for infection treated with monocyte/ neutrophil apheresis

Acronym

Evaluation trial of SPA-01

Scientific Title

Functional evaluation of neutrophil of patients at high risk for infection treated with monocyte/ neutrophil apheresis

Scientific Title:Acronym

Evaluation trial of SPA-01

Region

Japan


Condition

Condition

ulcerative colitis, large bowel perforation, esophageal cancer, colorectal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Open-label trial for monocyte/neutrophil apheresis (SPA-01) evaluate neutrophil function of patients at high risk for postoperative infection

Basic objectives2

Others

Basic objectives -Others

Identification of amount of blood apheresis needed for improvement in function of neutrophil

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Phase I,II


Assessment

Primary outcomes

Evaluation neutrophil function of patients at high risk for postoperative infection treated with monocyte/neutrophil apheresis

Key secondary outcomes

Identification of amount of blood apheresis needed for improvement in function of neutrophil


Base

Study type

Interventional


Study design

Basic design

Parallel

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

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

monocyte/neutrophil apheresis

Interventions/Control_2

non monocyte/neutrophil apheresis

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Following patients at high risk for postoperative infection
-wound class 2 and over
-with infection
-poor nutrition or general status
-undergo major-invasive surgery

Key exclusion criteria

-patients with cardiovascular disease (acute myocardial infarction, ischemic heart disease, or arrhythmia requiring treatment within 6 months of onset)
-with or with past histories of cerebral infarction or cerebrovascular disorder including intracerebral hemorrhage
-patients with hypotension or systolic blood pressure of 80mmHg and under
-pregnant or breast feeding women and women suspected of being pregnant
-demented persons
-patients with a histories of shock during extracorporeal circulation therapy
-patients receiving angiotensin-converting enzyme inhibitors and inappropriate in these drugs withdrawal prior to apheresis
-patients judged as inadequate for this study by attending physician

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshimitsu Araki

Organization

Mie University Hospital

Division name

Center of maternal and child health

Zip code


Address

2-174 Edobashi, Tsu, Mie, JAPAN

TEL

059-232-1111

Email

taraki@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshimitsu Araki

Organization

Mie University Hospital

Division name

Center of maternal and child health

Zip code


Address

2-174 Edobashi, Tsu, Mie, JAPAN

TEL

059-232-1111

Homepage URL


Email

taraki@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Hospital

Institute

Department

Personal name



Funding Source

Organization

Mie University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Infectious Diseases, Hiroshima University Graduate School of Medicine

Name of secondary funder(s)

Asahi Kasei Medical Co., Ltd.


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

三重大学医学部附属病院(三重県)
Mie University Hospital(Mie)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 08 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

Preinitiation

Date of protocol fixation

2013 Year 06 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 08 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

2013 Year 11 Month 08 Day

Last modified on

2014 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013113


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name