Status:
COMPLETED
Blood Management in Orthopedic Surgery
Lead Sponsor:
Sanquin Research & Blood Bank Divisions
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Roche BV Netherlands
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 a...
Eligibility Criteria
Inclusion
- Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).
Exclusion
- 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).
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
2598 Patients enrolled
Trial Details
Trial ID
NCT00998088
Start Date
May 1 2004
End Date
September 1 2009
Last Update
October 20 2009
Active Locations (4)
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1
Slotervaart Hospital
Amsterdam, North Holland, Netherlands
2
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands
3
Groene Hart Hospital
Gouda, South Holland, Netherlands
4
LUMC
Leiden, South Holland, Netherlands