The primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Crystalloid based prime solution
Erythrocyte based prime solution
Sahlgrenska University Hospital
Gothenburg, Sweden
Lactate level during and after perfusion.
Lactate level during and after perfusion.
Time frame: 1 hour
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
Time frame: 1 hour
Hematocrit during and after completion of perfusion.
Hematocrit during and after completion of perfusion.
Time frame: 1 hour
Oxygen extraction during, and after perfusion.
Oxygen extraction during, and after perfusion.
Time frame: 1 hour
Complications
Serious Adverse Events (SAEs) level III-V within 30 days.
Time frame: 30 days
Immunological effects
Changes in proportion of immune cells measured as CD3 + (T cells), CD3 + 4 + (helper T cells), CD3 + 8 + (cytotoxic T cells), CD3 + DR + (activated T cells), CD3 + 4 + 45RA + (naive helper T cells), CD3 + 8 + 45RA + (naïve cytotoxic T cells), CD3 + 4 + 45RO + (helper T cells), CD3 + 8 + 45RO + (cytotoxic memory T cells), CD3-56 + 16 + (NK cells), CD3 + 56 + 16 + (activated T cells), CD5 + (T-cells and some B-cells), CD19 + (B cells), CD5 + 19 + (subset of mature B cells mainly form polyspecific antibodies of the IgM class) will be measured before ILP, after 7 and 30 days post ILP
Time frame: 30 days
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