Blood Management in Orthopedic Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion Op Maat (TOMaat) Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: erythropoietin and cell saver
* Drug: erythropoietin
* Device: OrthoPAT
* Device: Post-operative drain device
* Other: Erythropoietin and OrthoPAT
* Other: Erythropoietin and drain device
* Device: OrthoPAT


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythropoietin<br> | Drug: erythropoietin<br>* weekly 40.000 IU s.c. for 4 weeks pre-operatively<br>* Other names: Neorecormon, Roche;|
| No Intervention: Control arm<br> | |
| Experimental: cell saver<br> | Device: OrthoPAT<br>* for intra- and post-operative re-infusion of autologous wound blood<br>* Other names: OrthoPAT, Haemonetics;Device: OrthoPAT<br>* For intra- and post-operative reinfusion of autologous blood<br>* Other names: OrthoPAT, Haemonetics;|
| Experimental: drain<br> | Device: Post-operative drain device<br>* For post-operative re-infusion of unwashed wound blood<br>* Other names: DONOR-drain, Van Straten Medical, The Netherlands;|
| Experimental: Erythropoietin and cell saver<br> | Other: erythropoietin and cell saver<br>* weekly 40.000 IU s.c. for 4 weeks pre-operatively; use of cell saver includes intra- and post-operative drainage and reinfusion<br>* Other names: OrthoPAT, Haemonetics;Other: Erythropoietin and OrthoPAT<br>* weekly 40.000 IU s.c. for 4 weeks pre-operatively<br>* Other names: OrthoPAT, Haemonetics;|
| Experimental: Erythropoietin and drain<br> | Other: Erythropoietin and drain device<br>* weekly 40.000 IE s.c.for 4 weeks pre-operatively; drain use in post-operative period<br>* Other names: DONOR-drain, Van Straten Medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of allogeneic red blood cell (RBC) transfusions. |  | up to 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood management, Orthopedic surgery, elective, randomized study, adults, hip replacement, knee replacement