NCT00127556

Brief Summary

This study concerns the safety of blood transfusion. Prior to transfusion, staff should perform a number of essential safety checks to ensure that the correct patient is receiving the correct blood product. Evidence suggests that these safety checks are not always done. This study has been designed to assess the effect of a simple intervention on the performance of the bedside safety check. The hypothesis is that a simple intervention will improve the performance of the bedside check.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Shorter than P25 for not_applicable

Geographic Reach
6 countries

12 active sites

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

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

First QC Date

August 4, 2005

Last Update Submit

May 6, 2008

Conditions

Keywords

TransfusionSafety

Outcome Measures

Primary Outcomes (3)

  • The primary endpoint is one proportion combining the 3 elements of the bedside check, that is: the proportion of transfusions in which the staff ask the patient to state his/her surname and first name and check that they are the same on the wristband

  • the proportion of transfusions in which the staff check to see that the patient's surname, first name and hospital number are the same on the wristband and on the label attached to the unit by the blood bank

  • the proportion of transfusions in which the staff check to see that the unit number is the same on the blood bag and on the label attached to the unit by the blood bank.

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Crossmatched red cells

You may not qualify if:

  • Uncrossmatched red cells, platelets, fresh frozen plasma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

LA County and USC Medical Centre

Los Angeles, California, 90033, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

Location

Dartmouth-Hitchcock Medical Centre

Lebanon, New Hampshire, 03756, United States

Location

Cincinnati Children's Hospital Medical Centre

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Hospital Sirio Libanes Blood Bank

São Paulo, 01308-050, Brazil

Location

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Sunnybrook & Women's Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

Haukeland University Hospital

Bergen, N-5021, Norway

Location

Great Ormond Street

London, United Kingdom

Location

Related Publications (1)

  • Murphy MF, Casbard AC, Ballard S, Shulman IA, Heddle N, Aubuchon JP, Wendel S, Thomson A, Hervig T, Downes K, Carey PM, Dzik WH; BEST Research Collaborative. Prevention of bedside errors in transfusion medicine (PROBE-TM) study: a cluster-randomized, matched-paired clinical areas trial of a simple intervention to reduce errors in the pretransfusion bedside check. Transfusion. 2007 May;47(5):771-80. doi: 10.1111/j.1537-2995.2007.01189.x.

    PMID: 17465940BACKGROUND

Related Links

Study Officials

  • Walter Dzik, MD

    Massachusetts General Hospital, USA

    PRINCIPAL INVESTIGATOR
  • Mike F Murphy, FRCPath, MD

    National Blood Service, England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 8, 2005

Study Start

April 1, 2005

Study Completion

December 1, 2005

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations