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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00127556




Registration number
NCT00127556
Ethics application status
Date submitted
4/08/2005
Date registered
8/08/2005
Date last updated
9/05/2008

Titles & IDs
Public title
Transfusion Medicine - Prevention of Bedside Errors
Scientific title
Cluster-Randomised Controlled Trial of a Simple Intervention to Prevent Bedside Checking Errors in Blood Transfusion
Secondary ID [1] 0 0
TM-PROBE study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Transfusion 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Label applied to blood bag

Treatment: Surgery: Label applied to blood bag
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Crossmatched red cells
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Uncrossmatched red cells, platelets, fresh frozen plasma

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New Hampshire
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Norway
State/province [7] 0 0
Bergen
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Dartmouth-Hitchcock Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
BEST research collaborative
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00127556
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Walter Dzik, MD
Address 0 0
Massachusetts General Hospital, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00127556