Osteoarthritis
Conditions
Keywords
Blood management, Orthopedic surgery, elective, randomized study, adults, hip replacement, knee replacement
Brief summary
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
Detailed description
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).
Interventions
OTHERerythropoietin 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
DRUGerythropoietin
weekly 40.000 IU s.c. for 4 weeks pre-operatively
DEVICEOrthoPAT
for intra- and post-operative re-infusion of autologous wound blood
DEVICEPost-operative drain device
For post-operative re-infusion of unwashed wound blood
OTHERErythropoietin and OrthoPAT
weekly 40.000 IU s.c. for 4 weeks pre-operatively
OTHERErythropoietin and drain device
weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Roche BV Netherlands
Haemonetics Corporation
Sanquin Research & Blood Bank Divisions
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).
Exclusion criteria
* Patients who refuse homologous blood (e.g.Jehovah's witnesses), * Patients with untreated hypertension (diastolic blood pressure \> 95 mm Hg), * Patients with a serious disorder of the coronary artery, peripheral arteries and/or carotid arteries, * A recent myocardial infarction or CVA, * Sickle cell anaemia patients, * Malignancy in the operated area, * Pregnancy, * Unsuitability for peri-operative anticoagulation prophylaxis, * Known allergy to erythropoietin, * An infected wound bed, * Revision of an infected prosthesis which is being treated with antibiotics, OR * Patients with difficulty understanding the Dutch language (unable to give informed consent or patients who insufficiently control the Dutch language).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of allogeneic red blood cell (RBC) transfusions. | up to 3 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Rehabilitation time | in hospital |
| Hb/Ht post-operative | at 14 days and 3 months after surgery |
| Quality of life | Up to 3 months after surgery |
| Peri- and post-operative complications during hospitalization | 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 |
| Transfusion reactions | up to 3 months after surgery |
Countries
Netherlands
Outcome results
None listed