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Sponsors and Collaborators: |
University of Heidelberg Philipps University Marburg Medical Center |
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Information provided by: | University of Heidelberg |
ClinicalTrials.gov Identifier: | NCT00176124 |
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 |
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Infection Bacterial Infection Sepsis |
Procedure: leukocyte depletion of whole blood Other: Leukocyte filtration/Depletion |
Phase IV |
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 |
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 |
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1: No Intervention
storage and transfusion of autologous whole blood without leukocyte depletion : Control group
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Procedure: leukocyte depletion of whole blood |
2: Experimental
storage and transfusion of leukocyte depleted autologous whole blood : leukocyte depletion group
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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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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• ASA I-III,
Exclusion Criteria:
Subjects with a contraindication for preoperative blood donation (PAD) (in 12, PP 36-43).
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 |
Study Chair: | Thomas Frietsch, MD, PhD | Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg |
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 |
leukocyte depletion, autologous transfusion, infection bacterial infection sepsis, antibiotics |
Systemic Inflammatory Response Syndrome Bacterial Infections Sepsis Inflammation |
Communicable Diseases Pathologic Processes Infection |