A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Study With the Aim to Compare Crystalloid Prime Solution With a Prime Solution Containing Packed Red Blood Cells in Relation to the Patient's Regional Metabolic Needs and Immunological Influence During Isolated Limb Perfusion

Conditions
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Melanoma, Sarcoma

Intervention / Treatment
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* Drug: Crystalloid based prime solution
* Drug: Erythrocyte based prime solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient scheduled for treatment with isolated hyperthermic perfusion Age over 18 years. Signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Erythrocyte based prime solution | Drug: Erythrocyte based prime solution<br>* Erythrocyte based prime solution<br>|
| Experimental: Intervention<br>Crystalloid based prime solution | Drug: Crystalloid based prime solution<br>* Crystalloid based prime solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate level during and after perfusion. | Lactate level during and after perfusion. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 hour | 
| Hematocrit during and after completion of perfusion. | Hematocrit during and after completion of perfusion. | 1 hour | 
| Oxygen extraction during, and after perfusion. | Oxygen extraction during, and after perfusion. | 1 hour | 
| Complications | Serious Adverse Events (SAEs) level III-V within 30 days. | 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 | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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isolated limb perfusion