|- candidate number||19282|
|- NTR Number||NTR4729|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-aug-2014|
|- Secondary IDs||14N102 METC Atrium-Orbis-Zuyd|
|- Public Title||Post-operative autologous transfusion of filtered shed blood in total knee arthroplasty: clinical bloodmanagement in everyday orthopaedic practice|
|- Scientific Title||Autologous blood transfusion after total knee arthroplasty|
|- hypothesis||Allogeneic blood transfusions are reduced when comparing the use of an ABT system to no use of post-operative drains in patients who underwent TKA. |
|- Healt Condition(s) or Problem(s) studied||Total knee arthroplasty, Blood transfusions|
|- Inclusion criteria||- Patients undergoing primary TKA |
- Surgery between January 2010 and December 2011
|- Exclusion criteria||- Secondary total knee arthroplasty|
- Rheumatoid arthritis (RA)
- Missing data regarding:
a. necessity and amount of autologous blood transfusion
b. necessity of allogeneic blood transfusion
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||18-aug-2014|
|- planned closingdate||31-dec-2014|
|- Target number of participants||750|
|- Interventions||Total knee arthroplasty (TKA) is associated with considerable blood loss, which may lead to post-operative anemia. To compensate for this blood loss, blood transfusions are sometimes necessary. Although the risks associated with allogeneic blood transfusions, such as transmittable diseases (e.g. HIV, hepatitis C and cytomegalovirus), allergic reactions and immunomodulatory effects are rare and have been minimized over the last years, public expectations are to have a zero-risk blood supply. As a result, alternative blood saving methods have become increasingly popular in treatment and prevention of post-operative anemia. One of these alternative blood saving methods is the use of post-operative draining systems with autologous blood transfusion (ABT). ABT systems have shown controversial results when it comes to decrease in use of allogeneic blood transfusions in TKA.|
|- Primary outcome||Primary outcome: |
- Peri-operative Hb levels:
o Standard measurement moments are:
„X Within 24 hours pre-operative. Usually the evening before surgery or the same morning before surgery.
„X One day post-operative
„X Three days post-operative
|- Secondary outcome||Secondary outcomes: |
- Allogeneic blood transfusion in the postoperative period.
The indication for allogeneic blood transfusion and amount of administered blood is registered in the EPD and is available for analysis. In our analysis we will mainly look at necessity of allogeneic blood transfusion in relation to whether a retransfusion system was applied (i.e. dichotomous variables). Differences in the units of packed cells administered will be analysed.
- Length of hospitalisation
o Normal length of stay after TKA is 3-5 days. Data will be collected from the EPD to analyse any prolonged or reduced length of stay. Any prolonged or reduced length of stay will then be analysed to check for possible complications.
o Events that have affected the overall patient outcome, required revision surgery or increased length of stay will be defined as postoperative complications. General non specific complications such as gastrointestinal-, urinary tract-, respiratory- or cardiac complications are not going to be included in the analysis but will be described.
- Amount of autologous blood transfused. The amount of retransfused blood (ml) is registered in our EPD.
|- Timepoints||Pre-, peri and 1, 2 and 3 days post operative HB levels.
Complication rate up to 6 months post operative
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. M.G.M. Schotanus|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M.G.M. Schotanus|
|- Sponsor/Initiator ||Orbis Medisch Centrum|
(Source(s) of Monetary or Material Support)
|- Brief summary||This retrospective study will evaluate the efficacy of an ABT system in TKA and compare it to the use of no drain in everyday practice. The primary research question is whether allogeneic blood transfusions are reduced when comparing the use of ABT systems to no use of post-operative drainage systems. As transfusion triggers tend to vary overtime and between hospitals, the primary outcome will be peri-operative Hb levels. In addition, variables that may have influenced peri-operative blood loss will be measured and analyzed.|
|- Main changes (audit trail)|
|- RECORD||11-aug-2014 - 3-sep-2014|