Leukocyte Depletion of Autologous Whole Blood
Condition: Infection; Bacterial Infection; Sepsis
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional
Phase: Phase 4

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
    

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 conditions
      such as methods, risks, assurance, data security, etc. The patient and the investigator
      should sign the informed consent form.

      Randomization:

      If all inclusion criteria are well given and exclusion criteria are absent, the patient could
      be enrolled and randomized, prior to the first PAD. Enrollment is parallel in all centers
      until the final number of 1088 is reached. Breaking the seal of the provided randomization
      envelope with computerized randomization codes completes randomization. Time and date should
      be noted.

      Blinding:

      Randomization is done by the investigator, which should manage the blood donation. The blood
      bags after inline leukocyte depletion prior to storage do not look different from not
      depleted bags and are labeled only with the patient's identity and the subjects ID. The
      allocation to the group is to keep secret from patient, surgeon and anesthesiologist.

      Treatment:

      A PAD:

      Group 1 Preoperative Donation of multiple units ( more than 2) 450 mL autologous whole blood
      and storage without leukocyte depletion Usual criteria and methods of PAD are used according
      to regional guidelines of blood donations in the respective center.

      Group 2 Preoperative Donation of multiple units (more than 2) 450 mL autologous whole blood
      and storage following leukocyte depletion 2 to 4 hours after whole blood donations, the whole
      blood bags should be in-line filtered by the use of leukocyte filtration sets (provided by
      Pall Medical Company). Storage as in group 1 at 4 degree C in a blood fridge.

      A as proposal, the Mannheim concept reveals a 95 percent security in avoidance of allogenic
      transfusions for a blood loss of 20-25 ml per kg body weight: Intended are 3 donations in
      weekly intervals. If Hb plasma con-tent decreases below 11 g/dL, the donation will be
      postponed to the fol-lowing week. Surgery is at the fifth week after the first donation.

      B Anesthesia and Surgery:

      As usual in the center, and without a difference between the two groups anesthesia and
      surgery should be performed under following aspects:

        -  At hospital admission, the actual history should be taken, study measures (Appendix 1)
           and screening laboratory should be withdrawn prior to anesthesia to compute the
           infection risk assessment of the respective patient 13.

        -  Both general and regional (spinal or epidural anesthesia) can be performed

        -  Normothermia of the patients is essential to the infection rate, hypothermia increases
           the infection rate by every degree! The intra- and postoperative core temperature range
           will be requested.

        -  Circulatory monitoring should be performed according to the centers conventions.
           Monitoring with a 5 channel ECG is suggested. Normovolemia is essential because
           hypovolemia is related to increased infection rate by hypoperfusion of the wound14-16.
           Therefore, a central venous catheter is useful but not obligatory, but urine output is
           required since it is a more sensitive volume indicator in absence of significant heart
           and renal failure (and common practice in hip surgery). An arterial line is not
           obligatory required.

        -  Bladder catheter (Urine production more than 1ml/kg KG/h)

        -  Cell Savers and hemodilution (iso- or hypervolemic) are not accepted.

        -  Blood loss is to calculate carefully by subtracting rinsing from suction volumes and
           weighing sponges and drapes intraoperatively. Postoperatively the drainage volumes are
           sufficient if not massive expansion of thighs or hip occurs ( however, this should be
           noted as AE).

        -  In the case that allogenic transfusion is required additionally, this should be
           leukodepleted.

        -  Intra- und postoperative transfusion trigger are similar for autologous and allogenic
           transfusion:

        -  Hb greater than 8,5 plus minus 0,5

        -  HF over 100 plusminus 10 /min or 35% above base line

        -  MAP below 60 plusminus 5 mmHg or 35% below base line

        -  Stenocardia, chest pain

        -  ST-segment changes greater than 0,2 ms

      Further documentation of

        -  ASA

        -  sex

        -  weight

        -  height

        -  Anesthesia duration

        -  OP-duration

        -  Blood loss(intra- and postoperatively)

        -  Lowest diastole. RR intraoperatively as well as postoperatively POD 0

        -  Time of transfusions

        -  Time of urine catheter withdrawal Infection-Monitoring

      Parameter:

      • Skin inspection

      Criteria of wound infection:

        -  secretion clear or pus,

        -  pos. bacterial culture,

        -  erythema

             -  Urine culture if indicated by sediment (at withdrawl of bladder cathe-ter,
                discolored urine or fever)

             -  Blood culture (if fever above 39°C after POD2)

             -  Tracheal secretion (if expectoration is prutride or radiological indica-tion of
                bronchopneumonia)

             -  Antibiotic treatment, duration, amounts, multidrug use

      Woundhealing and the occurrence of infections were classified with the ASEPSIS score: Of
      influence is the duration of antibiotic treatment, drainage of pus, wound de-bridements,
      erythema, involvement of deeper tissue layers, identification of bacteria, LOS above 14 days
      17.

      Infection Definition

      Occurrence of any infection is defined as

        -  Elevation of patient's temperature/fever above 38°C on POD 3 or later or

        -  Leukocytosis above the cut off point (generated for every individual subject )or

        -  BSG / CRP above the cut off point (generated for every individual subject ) or

        -  Isolation of bacteria from any fluid including pus or

        -  Abscess (verificated by surgical drainage or ultrasonographically guided aspiration of
           pus ) or

        -  Arthritis by local clinical symptoms and surgical drainage

      Wound infection is assessed by the ASEPSIS score

      Urinary tract infection is defined as

        -  new isolated occurrence of leukocytosis, and/or nitrite, and/or protein or

        -  isolation of bacteria more than 10 000/µl (sediment) or

        -  growth of more than 100 000 colonies of a single organism in the culture

      Respiratory airway infection is defined as

        -  positive x-ray (chest infiltrate) and fever or

        -  dyspnea or cough or purulent sputum and fever or

        -  isolation of bacteria in tracheal secretion (only intubated subjects) and fever

      Septicemia is defined as

      • clinical symptoms and positive blood culture
    

Intervention name(s): leukocyte depletion of whole blood; Leukocyte filtration/Depletion
Intervention type(s): Procedure; Other
Intervention description(s): 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 intervention name(s): Fresenius leukocyte depletion whole blood filters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: leukocyte depletion, autologous transfusion,; infection; bacterial infection; sepsis, antibiotics