|- candidate number||1502|
|- NTR Number||NTR303|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||ZonMW projectnumber: 945-06-601 |
|- Public Title||Optimal blood management in elective orthopaedic surgery. The Transfusion "Op Maat" (TOMaat) study.|
|- Scientific Title||Optimal blood management in elective orthopaedic surgery. The Transfusion "Op Maat" (TOMaat) study.|
|- ACRONYM||TOMaat study.|
|- hypothesis||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? |
|- Healt Condition(s) or Problem(s) studied||Total knee replacement (TKR), Total hip replacement (THR)|
|- Inclusion criteria||All orthopedic patients of 18 years and older being considered for a primary or revision total knee replacement (TKR) or total hip replacement (THR).|
|- Exclusion criteria||Refusal of allogeneic blood, pregnancy, patients with uncontrolled hypertension, cardiac instability, recent CVA, symptomatic atherosclerosis, sickle cell anaemia, cancer in the wound area , unsuitability for peri-operative anticoagulation prophylaxis, known allergy to erythropoietin and patients with an infected prosthesis or wound. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-mei-2004|
|- planned closingdate||31-dec-2008|
|- Target number of participants||2250|
|- Interventions||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.|
|- Primary outcome||Number of red blood cell (RBC) transfusions in the following blood management strategies:
1. Comparison of Epo versus no Epo;
2. Comparison of cell saver versus no cell saver;
3. Comparison of drain system versus no drain system, independent of cell saver. |
|- Secondary outcome||Postoperative complications, length of hospital stay (LOHS), postoperative Hb/haematocrit (Hct), rehabilitation time, mobility and functional abilities of knee-or hip, quality of life scores, costs analysis.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Cynthia So-Osman|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.G.H.H. Nelissen|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Orthopaedics|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Roche Nederland BV, Sanquin Bloodbank Amsterdam, Haemonetics BV|
|- Brief summary||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.
Primary outcome: number of allogeneic red blood cell (RBC) transfusions.
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;
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. |
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 20-sep-2006|