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


- candidate number1502
- NTR NumberNTR303
- ISRCTNISRCTN96327523
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsZonMW projectnumber: 945-06-601 
- Public TitleOptimal blood management in elective orthopaedic surgery. The Transfusion "Op Maat" (TOMaat) study.
- Scientific TitleOptimal blood management in elective orthopaedic surgery. The Transfusion "Op Maat" (TOMaat) study.
- ACRONYMTOMaat study.
- hypothesisDoes 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) studiedTotal knee replacement (TKR), Total hip replacement (THR)
- Inclusion criteriaAll orthopedic patients of 18 years and older being considered for a primary or revision total knee replacement (TKR) or total hip replacement (THR).
- Exclusion criteriaRefusal 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mei-2004
- planned closingdate31-dec-2008
- Target number of participants2250
- InterventionsStratification 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 outcomeNumber 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 outcomePostoperative 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.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Cynthia So-Osman
- CONTACT for SCIENTIFIC QUERIESDr. R.G.H.H. Nelissen
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Orthopaedics
- Funding
(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
- PublicationsN/A
- Brief summaryObjective/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.
- Main changes (audit trail)
- RECORD12-sep-2005 - 20-sep-2006


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