Condition category
Musculoskeletal Diseases
Date applied
29/09/2003
Date assigned
30/09/2003
Last edited
16/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Frietsch

ORCID ID

Contact details

Department of Anesthesiology and Critical Care Medicine
Faculty of Clinical Medicine Mannheim
Theodor-Kutzer-Ufer 1-3
Mannheim
67167
Germany
+49 (0)621 383 2415
thomas.frietsch@urz.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00176124

Protocol/serial number

N/A

Study information

Scientific title

Acronym

LDAWB2001

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/04/2002

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Added October 2008: 1089

Participant 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

Recruitment start date

01/04/2002

Recruitment end date

30/04/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Anesthesiology and Critical Care Medicine
Mannheim
67167
Germany

Sponsor information

Organisation

University of Heidelberg (Germany)

Sponsor details

Department of Anesthesiology and Critical Care Medicine
Faculty of Clinical Medicine Mannheim
University of Heidelberg
Mannheim
67167
Germany

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Auguste Schädler Stiftung, Dannstadt (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fresenius Medical Care AG, Bad Homburg (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Faculty of Clinical Medicine Mannheim, University of Heidelberg (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18564391

Publication citations

  1. Results

    Frietsch T, Karger R, Schöler M, Huber D, Bruckner T, Kretschmer V, Schmidt S, Leidinger W, Weiler-Lorentz A, Leukodepletion of autologous whole blood has no impact on perioperative infection rate and length of hospital stay., Transfusion, 2008, 48, 10, 2133-2142, doi: 10.1111/j.1537-2995.2008.01804.x.

Additional files

Editorial Notes