NCT03088865

Brief Summary

Implementation of the initial specimen diversion technique, in which the first milliliter of the venipuncture sample is not injected into the culture bottle, led to a significant reduction in blood culture contamination rates. This technique is based on the assumption that the skin plug aspirated during venipuncture is a major source of contaminating bacteria. One such diversion method is aspirating the first blood volume into a blood collection tube. It has, however, been suggested that regular blood collection tubes carry contaminants from the tube's stopper into the blood cultures drawn afterwards, thereby increasing contamination rates. The aim of this trial is to examine the effect of aspirating the first blood volume into a regular blood collection tube on blood culture contamination rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
756

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
Last Updated

July 29, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

March 9, 2017

Last Update Submit

July 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood culture contamination rate

    A blood culture contamination is defined as growth in a single set of coagulase-negative Staphylococcus, Micrococcus, Viridans group Streptococcus, Propionibacterium acne, Corynebacterium sp (diphtheroids) or Bacillus sp.

    7 days

Study Arms (2)

Initial Specimen Diversion

EXPERIMENTAL

Aspirating first blood volume into a regular blood collection tube

Diagnostic Test: aspirating first blood volume into a regular blood collection tube

Standard practice

ACTIVE COMPARATOR

Aspirating first blood into blood culture bottles (Standard practice)

Diagnostic Test: aspirating first blood volume into a regular blood collection tube

Interventions

order of blood drawing

Initial Specimen DiversionStandard practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults evaluated in the emergency room or as inpatients for suspected sepsis or having sepsis and from whom the treating physician plans to take, in the same venous puncture, blood cultures and additional blood tests (blood count and/or blood chemistry).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Lalezari A, Cohen MJ, Svinik O, Tel-Zur O, Sinvani S, Al-Dayem YA, Block C, Moses AE, Oster Y, Salameh S, Strahilevitz J. A simplified blood culture sampling protocol for reducing contamination and costs: a randomized controlled trial. Clin Microbiol Infect. 2020 Apr;26(4):470-474. doi: 10.1016/j.cmi.2019.09.005. Epub 2019 Sep 17.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 23, 2017

Study Start

September 1, 2017

Primary Completion

September 6, 2018

Study Completion

September 6, 2018

Last Updated

July 29, 2020

Record last verified: 2020-02

Locations