Blood Management in Orthopedic Surgery (TOMaat)
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|ClinicalTrials.gov Identifier: NCT00998088|
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : October 20, 2009
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).
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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Other: erythropoietin and cell saver Drug: erythropoietin Device: OrthoPAT Device: Post-operative drain device Other: Erythropoietin and OrthoPAT Other: Erythropoietin and drain device||Phase 4|
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 (CS or D) 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.
Knee surgery patients are not randomized for cell saver (no intra-operative blood loss).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2598 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study|
|Study Start Date :||May 2004|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2009|
weekly 40.000 IU s.c. for 4 weeks pre-operatively
|No Intervention: Control arm|
|Experimental: cell saver||
for intra- and post-operative re-infusion of autologous wound blood
Other Name: OrthoPAT, HaemoneticsDevice: OrthoPAT
For intra- and post-operative reinfusion of autologous blood
Other Name: OrthoPAT, Haemonetics
Device: Post-operative drain device
For post-operative re-infusion of unwashed wound blood
|Experimental: Erythropoietin and cell saver||
Other: erythropoietin and cell saver
weekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion
Other Names:Other: Erythropoietin and OrthoPAT
weekly 40.000 IU s.c. for 4 weeks pre-operatively
|Experimental: Erythropoietin and drain||
Other: Erythropoietin and drain device
weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period
- Number of allogeneic red blood cell (RBC) transfusions. [ Time Frame: up to 3 months after surgery ]
- Peri- and post-operative complications during hospitalization [ Time Frame: up to 3 months after surgery ]
- Rehabilitation time [ Time Frame: in hospital ]
- Hb/Ht post-operative [ Time Frame: at 14 days and 3 months after surgery ]
- Quality of life [ Time Frame: Up to 3 months after surgery ]
- Transfusion reactions [ Time Frame: up to 3 months after surgery ]
- Harris hip / knee society score (for determination of the mobility of the operated joint) [ Time Frame: pre-operative and after 3 months ]
- Cost analysis [ Time Frame: up to 3 months after surgery ]
- Length of hospital stay [ Time Frame: In hospital ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998088
|Amsterdam, Noord-Holland, Netherlands|
|Groene Hart Hospital|
|Gouda, Zuid Holland, Netherlands|
|Albert Schweitzer Hospital|
|Dordrecht, Zuid-Holland, Netherlands|
|Leiden, Zuid-Holland, Netherlands|
|Principal Investigator:||Rob Nelissen, MD, PhD||Leiden University Medical Center|