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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013269
Receipt No. R000015477
Scientific Title Functional evaluation of neutrophil of patients at high risk for infection treated with multiple monocyte/ neutrophil aphaereses
Date of disclosure of the study information 2014/02/25
Last modified on 2014/02/25

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Basic information
Public title Functional evaluation of neutrophil of patients at high risk for infection treated with multiple monocyte/ neutrophil aphaereses
Acronym Evaluation trial of multiple SPA-01
Scientific Title Functional evaluation of neutrophil of patients at high risk for infection treated with multiple monocyte/ neutrophil aphaereses
Scientific Title:Acronym Evaluation trial of multiple 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 multiple monocyte/neutrophil aphereses (SPA-01) evaluate neutrophil function of patients at high risk for postoperative infection
Basic objectives2 Others
Basic objectives -Others Identification of frequency 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 frequency 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 multiple 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 10

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
Institute Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Asahi Kasei Medical
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Infectious Diseases, Hiroshima University Graduate School of Medicine
Name of secondary funder(s) Department of Surgery 2, Tokyo Women's Medical University

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
2014 Year 02 Month 25 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
2014 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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
2014 Year 02 Month 25 Day
Last modified on
2014 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015477

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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