Blood TransfusionNCT00127556
Transfusion Medicine - Prevention of Bedside Errors
A study testing Label applied to blood bag in people with Blood Transfusion, run by Dartmouth-Hitchcock Medical Center at 12 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Transfusion
- What is being tested?
- Label applied to blood bag
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 12 sitesin 6 countries
- Study dates
- Apr 2005to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Crossmatched red cells
Who cannot join
- Uncrossmatched red cells, platelets, fresh frozen plasma
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02215
Cincinnati Children's Hospital Medical Centre
Cincinnati, Ohio, 45267
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Dartmouth-Hitchcock Medical Centre
Lebanon, New Hampshire, 03756
LA County and USC Medical Centre
Los Angeles, California, 90033
Canada2 sites
Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Sunnybrook & Women's Hospital
Toronto, Ontario, M4N 3M5
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: Cluster-Randomised Controlled Trial of a Simple Intervention to Prevent Bedside Checking Errors in Blood Transfusion
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.
Read the detailed description
The local collaborator at each participating hospital will identify two clinical areas comparable for the following elements: similar hours of service, similar use of red cells, similar level of intensity, and similar nurse-to-patient staffing ratios. For the purposes of this study, a clinical area is defined as a discrete area where one type of clinical care takes place. Comparability will be established by completion of a checklist.
The local collaborator will transmit comparability data to the study co-ordinator who will pass it on to a nominated medical consultant (Professor Mike Murphy) and the study statistician. If both parties are satisfied that the two clinical areas are comparable, confirmation will be transmitted to the local collaborator together with authority to commence the two-week baseline audit. Once the baseline is complete the local collaborator will contact the statistician, via the co-ordinator, to be informed of the area for intervention. The local collaborator will then inform the blood bank of the intervention area.
The intervention will be applied to one clinical area or ward in each participating hospital. Both clinical areas will be audited during a two-week baseline observation period. The two areas will then be randomly allocated to either the intervention of labeled blood bags or no intervention. Auditing will carry on in both areas until 2 weeks after the intervention has been introduced. To assess the longer-term impact of the intervention, there will be a further two-week period of audit 8 weeks from the start of the intervention. The intervention will be carried out for the full 10-week period.
The randomized comparison will be based on the data collected in the 2-week period after one area has received the labeled bags, and both areas have been observed by an observer for the same length of time. Thus the effect of the intervention will be separated from any initial effect that the observer may have on bedside checking practice. This comparison will also be made on the long-term audit data collected at 8-weeks.
The intervention under investigation is a simple label applied to the blood bag in such a way to cover (obstruct entry) the "ports" used to administer blood. The label will be applied to units of crossmatched red cells only. The position of the label will require that the user remove the label to administer the red cells. The label will state: "STOP: Check the patient's wristband". The wording will be translated to the appropriate language as necessary.
Observers (auditors)- not blinded to the test or control areas - will be asked to audit the bedside check at the time of transfusion. This will be done by direct observation. The auditor will take up a position to observe practice and will therefore be obvious to the staff. However the auditor will not participate in the transfusion check, not answer questions, and not reveal observed errors in the check (unless they observe that the wrong blood will be transfused, in which case they should intervene). Observations will be recorded on the data form.
Participants are invited from Europe, North America, South America, Asia and Australia. The target is for at least 15 hospitals.
- Conditions
- Blood Transfusion
- Being tested
- Label applied to blood bag
- Keywords
- Transfusion, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Label applied to blood bagProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startApr 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BEST research collaborative
- Investigators
- Walter Dzik, MD, Principal investigator, Massachusetts General Hospital, USAMike F Murphy, FRCPath, MD, Principal investigator, National Blood Service, England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127556
- Sponsor's protocol ID
- TM-PROBE study
- Status last verified
- May 2008
- First submitted
- 4 Aug 2005
- Last updated
- 9 May 2008
- Results posted
- No
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.
PubMed 17465940
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-Randomised Controlled Trial of a Simple Intervention to Prevent Bedside Checking Errors in Blood Transfusion
- ClinicalTrials.gov ID
- NCT00127556
- Acronym / sponsor ID
- TM-PROBE study
- Conditions
- Blood Transfusion
- Keywords
- Transfusion, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- BEST research collaborative
- Study start
- Apr 2005
- Study completion
- Dec 2005 (actual)
- First posted
- 8 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The local collaborator at each participating hospital will identify two clinical areas comparable for the following elements: similar hours of service, similar use of red cells, similar level of intensity, and similar nurse-to-patient staffing ratios. For the purposes of this study, a clinical area is defined as a discrete area where one type of clinical care takes place. Comparability will be established by completion of a checklist.
The local collaborator will transmit comparability data to the study co-ordinator who will pass it on to a nominated medical consultant (Professor Mike Murphy) and the study statistician. If both parties are satisfied that the two clinical areas are comparable, confirmation will be transmitted to the local collaborator together with authority to commence the two-week baseline audit. Once the baseline is complete the local collaborator will contact the statistician, via the co-ordinator, to be informed of the area for intervention. The local collaborator will then inform the blood bank of the intervention area.
The intervention will be applied to one clinical area or ward in each participating hospital. Both clinical areas will be audited during a two-week baseline observation period. The two areas will then be randomly allocated to either the intervention of labeled blood bags or no intervention. Auditing will carry on in both areas until 2 weeks after the intervention has been introduced. To assess the longer-term impact of the intervention, there will be a further two-week period of audit 8 weeks from the start of the intervention. The intervention will be carried out for the full 10-week period.
The randomized comparison will be based on the data collected in the 2-week period after one area has received the labeled bags, and both areas have been observed by an observer for the same length of time. Thus the effect of the intervention will be separated from any initial effect that the observer may have on bedside checking practice. This comparison will also be made on the long-term audit data collected at 8-weeks.
The intervention under investigation is a simple label applied to the blood bag in such a way to cover (obstruct entry) the "ports" used to administer blood. The label will be applied to units of crossmatched red cells only. The position of the label will require that the user remove the label to administer the red cells. The label will state: "STOP: Check the patient's wristband". The wording will be translated to the appropriate language as necessary.
Observers (auditors)- not blinded to the test or control areas - will be asked to audit the bedside check at the time of transfusion. This will be done by direct observation. The auditor will take up a position to observe practice and will therefore be obvious to the staff. However the auditor will not participate in the transfusion check, not answer questions, and not reveal observed errors in the check (unless they observe that the wrong blood will be transfused, in which case they should intervene). Observations will be recorded on the data form.
Participants are invited from Europe, North America, South America, Asia and Australia. The target is for at least 15 hospitals.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Crossmatched red cells
Key exclusion criteria (1 listed)
- Uncrossmatched red cells, platelets, fresh frozen plasma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Label applied to blood bag | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
- Background: PubMed 17465940Murphy 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.
- BEST collaborationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Dzik, MD principal investigator
Massachusetts General Hospital, USA
Mike F Murphy, FRCPath, MD principal investigator
National Blood Service, England
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Label applied to blood bag in people with Blood Transfusion, run by Dartmouth-Hitchcock Medical Center at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, Australia, Brazil, Norway and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00127556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2008.