NCT03966534

Brief Summary

A randomized partially controlled study to examine the effect of blood diversion into a heparin lithium tube on the incidence of blood culture contamination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
970

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
Last Updated

May 29, 2019

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

May 21, 2019

Last Update Submit

May 28, 2019

Conditions

Blood Culture Contamination

Outcome Measures

Primary Outcomes (1)

  • Blood culture contamination

    Growth of bacteria defined as blood culture contaminants (for example coagulase negative staphylococci in one bottle only).

    up to 7 days from obtaining blood culture

Secondary Outcomes (1)

  • Patient length of stay

    up to 3 months from arrival

Study Arms (2)

Control Group

NO INTERVENTION

Blood culture obtained as first test after venipuncture and prior to biochemistry test

Diversion Group

EXPERIMENTAL

Biochemistry test obtained as first test after venepuncture and prior to blood culture

Other: Blood diversion

Interventions

Blood diversionOTHER

Diversion of initial blood obtained at venipuncture to biochemistry tube in order to try and reduce incidence of blood culture contamination

Diversion Group

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Presence in Emergency Room during extended office hours (0800-2000 on weekdays(
  • Clinical requirement for Blood culture and biochemistry tests from venepuncture

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (1)

  • Zimmerman FS, Karameh H, Ben-Chetrit E, Zalut T, Assous M, Levin PD. Modification of Blood Test Draw Order to Reduce Blood Culture Contamination: A Randomized Clinical Trial. Clin Infect Dis. 2020 Aug 22;71(5):1215-1220. doi: 10.1093/cid/ciz971.

    PMID: 31570942DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective partially blinded randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 29, 2019

Study Start

September 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

May 29, 2019

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)