UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048582 |
|---|---|
| Receipt number | R000055194 |
| Scientific Title | Effect of standardized blood collection procedures from closed-needleless hub of vascular catheters by a blood collection specialist on blood-culture contamination rates, a retrospective cohort study |
| Date of disclosure of the study information | 2022/08/07 |
| Last modified on | 2022/08/04 12:38:41 |
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Basic information
Public title
Effect of standardized blood collection procedures from closed-needleless hub of vascular catheters by a blood collection specialist on blood-culture contamination rates, a retrospective cohort study
Acronym
Effect of standardized blood collection procedures from closed-needleless hub of vascular catheters by a blood collection specialist on blood-culture contamination rates, a retrospective cohort study
Scientific Title
Effect of standardized blood collection procedures from closed-needleless hub of vascular catheters by a blood collection specialist on blood-culture contamination rates, a retrospective cohort study
Scientific Title:Acronym
Effect of standardized blood collection procedures from closed-needleless hub of vascular catheters by a blood collection specialist on blood-culture contamination rates, a retrospective cohort study
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Medicine in general | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Several studies have been conducted on contamination rates, among which blood sampling from vascular catheters is known to increase the contamination rate. Therefore, blood sampling from peripheral veins is recommended in much of the literature, except in cases of suspected catheter-related bloodstream infection or when blood sampling from a peripheral vein is not feasible.
However, many previous reports of increased contamination rates with blood collection from vascular catheters have acknowledged multiple problems, including open blood collection, inconsistent blood collection techniques and blood collection by healthcare professionals not trained in blood collection from catheters. Recently, it has been reported that closed blood collection and blood collection by medical personnel trained in blood collection can reduce contamination rates, and the contamination rate of blood collection from vascular catheters may be lower than in the past, depending on the shape of the blood collection site of the device, the blood collection procedure and the medical personnel collecting blood. However, as far as we could find, there are no studies in which blood culture tests were drawn closed via vascular catheters using a strictly standardized procedure, and at present the contamination rate when blood is drawn closed via vascular catheters using a standardized procedure is unknown.
Blood collection from vascular catheters is generally easier and less painful, and if there is no difference in contamination rates compared with conventional methods, this would be of benefit to both healthcare staffs and patients. In the present study, we investigated retrospectively whether the contamination rate of blood culture test using blood collected from closed-needleless hubs of vascular catheters by a skilled medical staff using standardized procedure differs from the contamination rate when blood is collected in a conventional manner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contamination rates for blood culture tests
Key secondary outcomes
Positive rate of blood culture tests
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients for whom blood culture tests have been performed
Key exclusion criteria
none
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | TAKEFUMI |
| Middle name | |
| Last name | TSUNEMITSU |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
660-8550
Address
2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo, Japan
TEL
06-6480-7000
tsunemitsu0730@yahoo.co.jp
Public contact
Name of contact person
| 1st name | TAKEFUMI |
| Middle name | |
| Last name | TSUNEMITSU |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
660
Address
2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo, Japan
TEL
06-6480-7000
Homepage URL
tsunemitsu0730@yahoo.co.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan
Institute
Department
Personal name
Funding Source
Organization
none
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
Hyogo Prefectural Amagasaki General Medical Center Research Ethics Committee / Institutional Review Board
Address
2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo, Japan
Tel
0664807000
agmc.irb@gmail.com
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
| 2022 | Year | 08 | Month | 07 | 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
4500
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055194
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| Registered date | File name |
| Research case data | |
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