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Leukocyte Depletion of Autologous Whole Blood (LDAWB-2001)

This study has been completed.
Sponsor:
Collaborator:
Philipps University Marburg Medical Center
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00176124
First received: September 11, 2005
Last updated: June 9, 2008
Last verified: June 2008
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

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
No Intervention: 1
storage and transfusion of autologous whole blood without leukocyte depletion : Control group
 Procedure: leukocyte depletion of whole blood
Experimental: 2
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
Other Name: Fresenius leukocyte depletion whole blood filters

  Show Detailed Description

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

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

Publications:

Responsible Party: Thomas Frietsch, MD PhD, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00176124     History of Changes
Other Study ID Numbers: UniKlinMa-TF-2001-1, ISRCTN 99578441
Study First Received: September 11, 2005
Last Updated: June 9, 2008
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

Additional relevant MeSH terms:
Bacterial Infections
Sepsis
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013