Optimal blood management in elective orthopaedic surgery. The Transfusion "Op Maat" (TOMaat) study.

Objective/research questions:
What is the optimal transfusion management in elective orthopaedic surgery patients and what are the related costs?

Study design/intervention(s): a prospective, double randomised, 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 randomised for Erythropoietin (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 randomised. Patients in both strata will be randomised for three modalities: a cell saver (to wash, filter and reinfuse autologous shed blood) which is used intra- and postoperatively or a postoperative autologous reinfusion drainage system only (to filter and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls).

Study population/datasets: primary and revision total knee (TKR)-and hip replacement (THR) surgery patients.

Outcome measures:
Primary outcome: number of allogeneic red blood cell (RBC) transfusions.
Hypotheses:
1. comparison of Epo versus no Epo;
2. comparison of cell saver versus no cell saver;
3. comparison of drain versus no drain Secondary outcome:
1. postoperative complications;
2. length of hospital stay (LOHS);
3. postoperative Hb;
4. Quality of life;
5. functional Hip-,or Knee- scores;
6. rehabilitation;
7. costs analysis.

Power/data analysis: In order to be able to detect a 75% reduction of allogeneic transfusions by Epo and a reduction of 30% by autologous (shed blood) transfusions (cell saver or postoperative drain) with a power= 0.9 and an alpha= 0.05, inclusion of 2250 surgery patients (in a worst case scenario of high standard deviations) are required for intention-to-treat analysis.

Economic evaluation: analysis of short-term direct medical costs, including bloodproducts, Epo, cell saver, postoperative autologous blood reinfusion drain systems.

Does the use of alternatives to allogeneic blood (erythropoietin or reinfusion of autologous shed blood intra- and/or postoperatively) for patients undergoing elective total knee- or hip replacement surgery lead to continuous sparing of allogeneic blood if a restrictive transfusion policy is in operation?

Stratification depending on the pre-operative Hemoglobin (Hb) level:
Stratum I: 6,1 mmol/L < Hb < 8,2 mmol /L (eligible for Epo randomisation)
Stratum II: Hb < 6,2 mmol/L or >8,1 mmol/L (not eligible for Epo).
Patients in both strata will be sequentially randomised for:
a. no use of autologous wound-drained blood (control group)
b. post-operative retransfusion of wound-drained blood or
c. peri-operative use of the cell saver with post-operative retransfusion of wound-drained blood.