|- candidate number||15036|
|- NTR Number||NTR4044|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-jun-2013|
|- Secondary IDs|| |
|- Public Title||De-implementation of non cost-effective blood saving measures in total hip and knee replacement|
|- Scientific Title||The Leiden implementation study of blood management in hip and knee arthroplasties (LISBOA), a RCT to evaluate a de-implementation intervention|
|- hypothesis||This 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) studied||Implementation, 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 received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2013|
|- planned closingdate||1-mrt-2015|
|- Target number of participants||20|
|- 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 outcome||The primary outcome is the % of patients undergoing primary elective total hip or knee arthroplasty in which EPO or blood salvage is applied.|
|- Secondary outcome||Secondary 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.|
|- Timepoints||Because 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 site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| V.M.A. Voorn|
|- CONTACT for SCIENTIFIC QUERIES|| L. van Bodegom - Vos Vos|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Sanquin Blood Supply|
|- Brief summary||Hospital-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)|
|- RECORD||25-jun-2013 - 5-jan-2016|