UMIN-CTR Clinical Trial

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
Email	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
Email	tsunemitsu0730@yahoo.co.jp

Sponsor
Institute	Department of Emergency and Critical Care Medicine, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055194