Aim: to investigate whether the use of several transfusion alternatives (erythropoietin, the
cell-saver or postoperative drainage and reinfusion systems) in patients undergoing elective
total knee or hip replacement surgery can lead to allogeneic red blood cell (RBC) saving if a
restrictive transfusion policy is used.
Study design: a prospective, double randomized, open, multicenter study in which patients are
stratified according to their preoperative hemoglobin(Hb) level: stratum I= Hb between 6,1
and 8,2 mmol/l. These patients are first randomized for Erythropoetin (Epo) or no Epo.
Stratum II= Hb of 6,1 and lower or 8,2 mmol/l and higher, are not eligible for Epo and thus
not randomized. Patients in both strata will be randomized for three modalities: a cell saver
(CS)(to wash, filter and reinfuse autologous shed blood) which is used intra- and
postoperatively or a postoperative autologous reinfusion drainage system (D) only (to filter
and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls).
Inclusion criteria: All orthopedic patients of 18 years and older being considered for a
primary or revision total knee- (TKR) or total hip replacement (THR).
Outcome measures:
Primary outcome: number of allogeneic red blood cell (RBC) transfusions.
Secondary outcome: transfusion reactions, rehabilitation time, length of hospital stay
(days), peri- and post-operative complications during hospitalization, quality of life, cost
analysis
Phase:
Phase 4
Details
Lead Sponsor:
Sanquin Research & Blood Bank Divisions
Collaborators:
Haemonetics Corporation Roche BV Netherlands ZonMw: The Netherlands Organisation for Health Research and Development