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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN96327523 | |||
| NTR303 | |||
| ZonMW945-06-601 | |||
| Sanquin PPOC-03-002 |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Roche BV Netherlands | UNKNOWN |
| Haemonetics Corporation | INDUSTRY |
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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).
Outcome measures:
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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythropoietin | Experimental |
| |
| Control arm | No Intervention | ||
| cell saver | Experimental |
| |
| drain | Experimental |
| |
| Erythropoietin and cell saver | Experimental |
| |
| Erythropoietin and drain | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erythropoietin and cell saver | Other | weekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of allogeneic red blood cell (RBC) transfusions. | up to 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Peri- and post-operative complications during hospitalization | up to 3 months after surgery | |
| Rehabilitation time | in hospital | |
| Hb/Ht post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rob Nelissen, MD, PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slotervaart Hospital | Amsterdam | North Holland | Netherlands | |||
| Albert Schweitzer Hospital |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D000068817 | Epoetin Alfa |
| C103998 | epoetin beta |
| D004322 | Drainage |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| erythropoietin | Drug | weekly 40.000 IU s.c. for 4 weeks pre-operatively |
|
|
| OrthoPAT | Device | for intra- and post-operative re-infusion of autologous wound blood |
|
|
| Post-operative drain device | Device | For post-operative re-infusion of unwashed wound blood |
|
|
| Erythropoietin and OrthoPAT | Other | weekly 40.000 IU s.c. for 4 weeks pre-operatively |
|
|
| Erythropoietin and drain device | Other | weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period |
|
|
| OrthoPAT | Device | For intra- and post-operative reinfusion of autologous blood |
|
|
| at 14 days and 3 months after surgery |
| Quality of life | Up to 3 months after surgery |
| Transfusion reactions | up to 3 months after surgery |
| Harris hip / knee society score (for determination of the mobility of the operated joint) | pre-operative and after 3 months |
| Cost analysis | up to 3 months after surgery |
| Length of hospital stay | In hospital |
| Dordrecht |
| South Holland |
| Netherlands |
| Groene Hart Hospital | Gouda | South Holland | Netherlands |
| LUMC | Leiden | South Holland | Netherlands |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |