Leukocyte Depletion of Autologous Whole Blood

NCT00176124 | Completed Phase 4 DMC

• 2 other identifiers: UniKlinMa-TF-2001-1ISRCTN 99578441
• Study Type: interventional
• Target: 1,089
• Locations: 1 country
• Sites: 3

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 retransfusion perioperatively during hip arthroplasty and allogenic transfusion rate

Conditions

Infection; Bacterial Infection; Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay

  90 days

Secondary Outcomes (1)

• Blood loss and transfusion rate

  90 days

Study Arms (2)

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

Interventions

leukocyte depletion of whole blood PROCEDURE

1; 2

Leukocyte filtration/Depletion OTHER

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

Also known as: Fresenius leukocyte depletion whole blood filters

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Heidelberg University: lead
• Philipps University Marburg: collaborator

Study Sites (3)

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

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Klinikum Garmisch Partenkirchen

Garmisch-Partenkirchen, Bavaria, 82467, Germany

Location

Institute of Transfusion Medicine and Hemostasiology, University of MArburg

Marburg, 35043, Germany

Location

Related Publications (6)

• Byrne DJ, Malek MM, Davey PG, Cuschieri A. Postoperative wound scoring. Biomed Pharmacother. 1989;43(9):669-73. doi: 10.1016/0753-3322(89)90085-1.

  PMID: 2696565 BACKGROUND

• 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. doi: 10.1046/j.1537-2995.2001.41040470.x.

  PMID: 11316896 BACKGROUND

• 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. doi: 10.1046/j.1423-0410.2001.00107.x.

  PMID: 11703863 BACKGROUND

• 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.

  PMID: 2058822 BACKGROUND

• 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. doi: 10.1046/j.1423-0410.2001.00106.x.

  PMID: 11703862 BACKGROUND

• Frietsch T, Lorentz A. Predonation of autologous blood is jeopardized by new regulations. Eur J Anaesthesiol. 2001 Oct;18(10):629-31. doi: 10.1046/j.1365-2346.2001.00997.x. No abstract available.

  PMID: 11553239 BACKGROUND

MeSH Terms

Conditions

Infections; Bacterial Infections; Sepsis

Interventions

Leukocyte Reduction Procedures

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Thomas Frietsch, MD, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2001
• Primary Completion: April 1, 2005
• Study Completion: September 1, 2005
• Last Updated: June 10, 2008

Record last verified: 2008-06

Locations

DE (3)