Status:
COMPLETED
Leukocyte Depletion of Autologous Whole Blood
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Philipps University Marburg
Conditions:
Infection
Bacterial Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 re...
Detailed Description
Informed Consent Form: Prior to the first blood donation, in- and exclusion criteria should be tested. Then the patient is to inform by the investigator about the studies aim and participation condit...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
1089 Patients enrolled
Trial Details
Trial ID
NCT00176124
Start Date
April 1 2001
End Date
September 1 2005
Last Update
June 10 2008
Active Locations (3)
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1
Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany
Mannheim, Baden-Wurttemberg, Germany, 68167
2
Klinikum Garmisch Partenkirchen
Garmisch-Partenkirchen, Bavaria, Germany, 82467
3
Institute of Transfusion Medicine and Hemostasiology, University of MArburg
Marburg, Germany, 35043