Optimal blood management in elective orthopaedic surgery: the Transfusion Op Maat (TOMaat) study
Not Applicable
Completed
- Conditions
- Total Knee Replacement (TKR)/Total Hip Replacement (THR)Surgery
- Registration Number
- ISRCTN96327523
- Lead Sponsor
- eiden University Medical Centre (LUMC) (Netherlands)
- Brief Summary
2020 results in https://pubmed.ncbi.nlm.nih.gov/32963331/ (added 26/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 3689
Inclusion Criteria
All orthopedic patients of 18 years and older being considered for a primary or revision total knee replacement (TKR) or total hip replacement (THR).
Exclusion Criteria
1. Refusal of allogeneic blood
2. Pregnancy
3. Patients with uncontrolled hypertension
3. Cardiac instability
4. Recent CVA
5. Symptomatic atherosclerosis
6. Sickle cell anaemia
7. Cancer in the wound area
8. Unsuitability for peri-operative anticoagulation prophylaxis
9. Known allergy to erythropoietin
10. Infected prosthesis or wound
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Number of red blood cell (RBC) transfusions in the following blood management strategies:<br> 1. Comparison of Epo versus no Epo<br> 2. Comparison of cell saver versus no cell saver<br> 3. Comparison of drain system versus no drain system, independent of cell saver<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Post-operative complications<br> 2. Length of hospital stay (LOHS)<br> 3. Post-operative Hb/haematocrit (Hct)<br> 4. Rehabilitation time<br> 5. Mobility and functional abilities of knee-or hip<br> 6. Quality of life scores<br> 7. Costs analysis<br>