Leukocyte Depletion of Autologous Whole Blood: impact on perioperative infection rate and length of hospital stay for hip arthroplasty patients
| ISRCTN | ISRCTN99578441 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99578441 |
| ClinicalTrials.gov (NCT) | NCT00176124 |
| Protocol serial number | N/A |
| Sponsor | University of Heidelberg (Germany) |
| Funders | Auguste Schädler Stiftung, Dannstadt (Germany), Fresenius Medical Care AG, Bad Homburg (Germany), Faculty of Clinical Medicine Mannheim, University of Heidelberg (Germany) |
- Submission date
- 29/09/2003
- Registration date
- 30/09/2003
- Last edited
- 16/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thomas Frietsch
Scientific
Scientific
Department of Anesthesiology and Critical Care Medicine
Faculty of Clinical Medicine Mannheim
Theodor-Kutzer-Ufer 1-3
Mannheim
67167
Germany
| Phone | +49 (0)621 383 2415 |
|---|---|
| thomas.frietsch@urz.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | LDAWB2001 |
| Study objectives | Added as of 16/12/2008: Leukocyte depletion of autologous whole blood prior to storage does not reduce infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay but may increase retransfusion perioperatively during hip arthroplasty and allogenic transfusion rate. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Arthrosis of the hip |
| Intervention | Autologous blood donation, storage either as leukocyte depleted or undepleted whole blood, retransfusion perioperatively during hip arthroplasty, comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay |
| Intervention type | Other |
| Primary outcome measure(s) |
Added as of 16/12/2008: |
| Key secondary outcome measure(s) |
Added as of 16/12/2008: |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 1089 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Anesthesiology and Critical Care Medicine
Mannheim
67167
Germany
67167
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No |
