TOMaat study

Study is closed

Rationale

Patient Blood Management promotes the combined use of transfusion alternatives. Because such studies are lacking, we conducted a large randomized study on the integrated use of erythropoietin, cell saver and/or postoperative drain re-infusion devices as allogeneic red blood cell sparing alternatives to evaluate red blood cell transfusion while applying a restrictive transfusion threshold. 

Objective

To investigate whether the use of alternatives to allogeneic blood for patients undergoing elective total knee or hip replacement surgery, e.g. the infusion of erythropoietin, the use of the cell-saver or the reinfusion of autologous wound drained blood, can lead to continuous sparing of allogeneic blood if a restrictive  transfusion policy is used. The effect on post-operative complications, length of hospital stay, mobilization and rehabilitation, and the quality of life in relation to the estimated cost will also be investigated.

Study design

Multicenter randomized controlled study.

Methods

Patients are stratified depending on the pre-operative Hb level. The inclusion criteria required for erythropoietin randomization is a Hb > 6.1 mmol / l and < 8.2 mmol / l (stratum I, arm A and B). Patients in I A, 1B and II will be sequentially randomized for:
a) no use of autologous wound-drained blood
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

All patients will be transfused according to a uniform restrictive transfusion policy.

Study population

All orthopedic patients of 18 years and older being considered for a total knee replacement (TKR), total hip replacement (THR) or TKR/THR revision.

Main study parameters/endpoints

Primary end point

• Mean and percentage transfused red blood cell transfusions.

Secondary end points

• Transfusion reactions
• Peri- and post-operative complications up to 3 months postoperatively
• Length of hospital stay (days)
• Rehabilitation time
• Hb/Ht post-operative, on discharge / at 14 days and at 3 months
• Quality of life
• arris hip / knee society score (for determination of the mobility of the operated joint) pre-operative and after 3 monthsCost analysis

Research Staff

• Prof A Brand MD PhD
• Prof RGHH Nelissen MD PhD
• C So-Osman MD PhD

Publications

So-Osman C, Nelissen RG, Koopman-van Gemert AW, Kluyver E, Pöll RG, Onstenk R, Van Hilten JA, Jansen-Werkhoven TM, van den Hout WB, Brand R, Brand A. Patient Blood Management in Elective Total Hip- and Knee-replacement Surgery (Part 1): A Randomized Controlled Trial on Erythropoietin and Blood Salvage as Transfusion Alternatives Using a Restrictive Transfusion Policy in Erythropoietin-eligible Patients. Anesthesiology 2014;120(4):839-51.

So-Osman C, Nelissen RG, Koopman-van Gemert AW, Kluyver E, Pöll RG, Onstenk R, Van Hilten JA, Jansen-Werkhoven TM, van den Hout WB, Brand R, Brand A. Patient Blood Management in Elective Total Hip- and Knee-replacement Surgery (Part 2): A Randomized Controlled Trial on Blood Salvage as Transfusion Alternative Using a Restrictive Transfusion Policy in Patients with a Preoperative Hemoglobin above 13 g/dl. Anesthesiology 2014;120(4):852-60.

Voorn VM, Marang-van de Mheen PJ, Wentink MM, So-Osman C, Vliet Vlieland TP, Koopman-van Gemert AW, Nelissen RG, Van Bodegom-Vos L; LISBOA study group. Frequent use of blood-saving measures in elective orthopaedic surgery: a 2012 Dutch blood management survey. BMC Musculoskelet Disord 2013; 14:230.