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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Erythrocyte based prime solution |
|
| Intervention | Experimental | Crystalloid based prime solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystalloid based prime solution | Drug | Crystalloid based prime solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate level during and after perfusion. | Lactate level during and after perfusion. | 1 hour |
| 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. |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35575302 | Derived | Corderfeldt Keiller A, Holmen A, Hansson C, Ricksten SE, Bragadottir G, Olofsson Bagge R. Non-invasive and invasive measurement of skeletal muscular oxygenation during isolated limb perfusion. Perfusion. 2023 Jul;38(5):1019-1028. doi: 10.1177/02676591221093201. Epub 2022 May 16. |
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| Erythrocyte based prime solution |
| Drug |
Erythrocyte based prime solution |
|
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 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
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