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
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
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
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
