eukocyte Depletion of Autologous Whole Blood: impact on perioperative infection rate and length of hospital stay for hip arthroplasty patients
- Conditions
- Arthrosis of the hipMusculoskeletal DiseasesArthrosis
- Registration Number
- ISRCTN99578441
- Lead Sponsor
- niversity of Heidelberg (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1089
Hip arthroplasty patients
Added as of 16/12/2008:
1. American Society of Anaesthesiologists (ASA) grade I - III
2. Aged 18 - 85 years
3. Body weight 50 - 125 kg
4. If female, with either a history of an accepted method of anticonception for at least 3 months prior and 1 month following the termination of the study or climacteric or with a negative beta-human chorionic gonadotropin (B-HCG) test in urine or serum
5. Pre-operative blood donation of at least 2 units (450 ml whole blood)
6. Pre-operative haemoglobin level greater than 10 mg/dl
7. Able and willing to sign informed consent
Added 16/12/2008:
1. Subjects with a contraindication for pre-operative blood donation (PAD)
2. Systemic infection
3. Acute bacterial or viral diseases
4. Anaemia (haemogoblin [Hb] greater than 11 g/dL)
5. Myocardial infarction within the past 6 months
6. Unstable angina pectoris
7. Vascular stenosis (i.e. of the coronary or internal carotid arteries)
8. Haemodynamic relevant valvular stenosis
9. Heart failure greater than New York Heart Association (NYHA) II
10. History of strokes or transient ischaemic attack (TIA)
11. Steroid therapy
12. Immune deficiency
13. Haematological or endocrinological disease
14. Coagulopathy
15. History of organ transplantation
16. Simultaneous participation in a second study
17. Pregnancy
18. Membership at Jehovah's Witnesses
19. Intended use of a cell saver
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method