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De-implementation of non cost-effective blood saving measures in total hip and knee replacement


- candidate number15036
- NTR NumberNTR4044
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jun-2013
- Secondary IDs 
- Public TitleDe-implementation of non cost-effective blood saving measures in total hip and knee replacement
- Scientific TitleThe Leiden implementation study of blood management in hip and knee arthroplasties (LISBOA), a RCT to evaluate a de-implementation intervention
- ACRONYMLISBOA
- hypothesisThis study aims to change the blood management behavior of orthopedic surgeons and anesthesiologists in primary elective total hip and knee arthroplasties, using a tailored intervention strategy for de-implementation of EPO and blood salvage.

The hypothesis is that the intervention results in an absolute decrease of 20% in patients receiving EPO or blood salvage in comparison to usual care (control intervention).
- Healt Condition(s) or Problem(s) studiedImplementation, Total Hip Arthroplasty, Total knee arthroplasty, Behavioural change, Blood Management
- Inclusion criteria- Hospitals using EPO and/or blood salvage in patients undergoing primary elective THA or TKA on a regular basis (more frequently than in exceptional cases)
- Hospitals performing at least 50 THA and/or TKA on average per 5 months.
- Exclusion criteria- Hospitals considering to abandon the use of EPO or blood salvage on their own initiative
- Hospitals participating in trials that interfere with the use or the discontinuation of EPO or blood salvage
- Hospitals employing the same group of orthopaedic surgeons or anaesthesiologists as a previous included hospital.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2013
- planned closingdate1-mrt-2015
- Target number of participants20
- Interventions- Interactive education aimed at orthopedic surgeons and anesthesiologists
- Feedback in an educational outreach visit aimed at orthopedic surgeons and anesthesiologists
- Dissemination and reports on hospital performance/ best practices aimed at orthopedic surgeons and anesthesiologists
- Information letter/ email aimed at other involved professionals (transfusion committee, OR-personnel, pharmacists).
- Primary outcomeThe primary outcome is the % of patients undergoing primary elective total hip or knee arthroplasty in which EPO or blood salvage is applied.
- Secondary outcomeSecondary study parameters are the patient outcomes of the surgery including post-operative hemoglobin (Hb) level, length of hospital stay and number of allogeneic transfusions. Also possible complications will be registered: reactions on EPO use, transfusion reactions due to the use of blood salvage, transfusion reactions due to allogeneic transfusions, other (serious) adverse events.
- TimepointsBecause the alternative study design, the measurement points are not patient-related but predetermined. The measurement points are: 1st August to 31 December 2013 baseline. October 1st 2014 to February 28th 2015 follow-up. The months in between: January 1, 2014 to September 30, 2014 form the intervention period.
- Trial web siteN/A
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES V.M.A. Voorn
- CONTACT for SCIENTIFIC QUERIES L. van Bodegom - Vos Vos
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Sanquin Blood Supply
- PublicationsN/A
- Brief summaryHospital-clustered RCT comparing a tailored de-implementation intervention with no intervention in 20 hospitals to change the blood management behavior of orthopedic surgeons and anesthesiologists.
- Main changes (audit trail)
- RECORD25-jun-2013 - 8-jul-2013


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