Leukocyte Depletion of Autologous Whole Blood - Full Text View

Sponsors and Collaborators:	University of Heidelberg Philipps University Marburg Medical Center
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00176124

Purpose

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

Condition	Intervention	Phase
Infection Bacterial Infection Sepsis	Procedure: leukocyte depletion of whole blood Other: Leukocyte filtration/Depletion	Phase IV

MedlinePlus related topics: Antibiotics Bacterial Infections Blood Transfusion and Donation Sepsis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Leukocyte Depletion of Autologous Whole Blood: Impact on Perioperative Infection Rate and Length of Hospital Stay for Hip Arthroplasty Patients

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Blood loss and transfusion rate [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment:	1089
Study Start Date:	April 2001
Study Completion Date:	September 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention storage and transfusion of autologous whole blood without leukocyte depletion : Control group	Procedure: leukocyte depletion of whole blood
2: Experimental storage and transfusion of leukocyte depleted autologous whole blood : leukocyte depletion group	Procedure: leukocyte depletion of whole blood Other: Leukocyte filtration/Depletion leukocyte depletion filters as used routinely: filters (prestorage) inherent to the blood bag sets by gravity force following storage on cold plate for 2 hours

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Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• ASA I-III,
- Age 18-85 years,
- Body weight 50-125 kg
- If female, with either a history of an accepted method of anticonception for at least 3 month prior and 1 month following the termination of the study or climacteric or with a negative betA- HCG-Test in urine or serum.
- Preoperative blood donation of at least 2 units (450mL whole blood)
- Preoperative hemoglobin level > 10 mg/dL
- Able and willing to sign informed consent

Exclusion Criteria:

Subjects with a contraindication for preoperative blood donation (PAD) (in 12, PP 36-43).
- systemic infection
- acute bacterial or viral diseases
- anemia (Hb > 11g/dL)
- myocardial infarction within the past 6 month,
- instable angina pectoris
- vascular stenosis (i.e. of the coronary or internal carotid arteries)
- hemodynamic relevant valvular stenosis
- heart failure > NYHA II
- history of strokes or TIA
- steroid therapy,
- immune deficiency,
- hematological or endocrinological disease,
- coagulopathy,
- history of organ transplantation,
- simultaneous participation in a second study
- pregnancy
- membership at Jehovah's Witnesses
- intended use of a cell saver

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176124

Locations

Germany
Institute of Transfusion Medicine and Hemostasiology, University of MArburg
Marburg, Germany, 35043
Germany, Baden-Wuerttemberg
Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany
Mannheim, Baden-Wuerttemberg, Germany, 68167
Germany, Bavaria
Klinikum Garmisch Partenkirchen
Garmisch Partenkirchen, Bavaria, Germany, 82467

Sponsors and Collaborators

University of Heidelberg

Philipps University Marburg Medical Center

Investigators

Study Chair:

Thomas Frietsch, MD, PhD

Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg

More Information

-Forschung, - Arbeitsgruppen, -Autologe Transfusionsverfahren , -Projekte, -How To Store Autologous Blood - Invitation to join a Multicenter Study This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Byrne DJ, Malek MM, Davey PG, Cuschieri A. Postoperative wound scoring. Biomed Pharmacother. 1989;43(9):669-73.

Frietsch T, Fessler H, Kirschfink M, Nebe T, Waschke KF, Lorentz A. Immune response to autologous transfusion in healthy volunteers: WB versus packed RBCs and FFP. Transfusion. 2001 Apr;41(4):470-6. Erratum in: Transfusion 2001 Jun;41(6):851.

Frietsch T, Krombholz K, Tolksdorf B, Nebe T, Segiet W, Lorentz A. Cellular immune response to autologous blood transfusion in hip arthroplasty: whole blood versus buffy coat-poor packed red cells and fresh-frozen plasma. Vox Sang. 2001 Oct;81(3):187-93.

Lorentz A, Osswald PM, Schilling M, Jani L. [A comparison of autologous transfusion procedures in hip surgery] Anaesthesist. 1991 Apr;40(4):205-13. German.

Tolksdorf B, Frietsch T, Quintel M, Kirschfink M, Becker P, Lorentz A. Humoral immune response to autologous blood transfusion in hip surgery: whole blood versus packed red cells and plasma. Vox Sang. 2001 Oct;81(3):180-6.

Frietsch T, Lorentz A. Predonation of autologous blood is jeopardized by new regulations. Eur J Anaesthesiol. 2001 Oct;18(10):629-31. No abstract available.

Responsible Party:	University of Heidelberg ( Thomas Frietsch, MD PhD )
Study ID Numbers:	UniKlinMa-TF-2001-1, ISRCTN 99578441
Study First Received:	September 11, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00176124
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

leukocyte depletion, autologous transfusion,
infection
bacterial infection
sepsis, antibiotics

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Sepsis
Inflammation

Additional relevant MeSH terms:

Communicable Diseases
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009