Leukocyte Depletion of Autologous Whole Blood: impact on perioperative infection rate and length of hospital stay for hip arthroplasty patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99578441

Enrollment

1089

Registered

2003-09-30

Start date

2002-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrosis of the hip Musculoskeletal Diseases Arthrosis

Interventions

Autologous blood donation, storage either as leukocyte depleted or undepleted whole blood, retransfusion perioperatively during hip arthroplasty, comparison of infection rate (wound, urinary tract, ot

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Added as of 16/12/2008: Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay, measured at 90 days	—

Secondary

Measure	Time frame
Added as of 16/12/2008: Blood loss and transfusion rate, measured at 90 days	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026