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| Name | Class |
|---|---|
| Complexo Hospitalario Universitario de A Coruña | OTHER |
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Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
The purpose of the PERTRIAL clinical investigation is to demonstrate the Performance and Safety of Perla® Cold Preservation solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perla® Cold Preservation solution | Experimental | Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perla® Cold Preservation solution | Drug | Perla® must be cooled to 2° to 6 °C prior to use. The cold Preservation Solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation. |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Function Rate (Kidney & Liver) | 7 days post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Graft survival (Kidney & Liver) | 7 days post-transplant | |
| Graft survival (Kidney & Liver) | 14 & 30 days post-transplant | |
| Rate of an event or serious adverse device effects (Kidney & Liver) |
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Donor kidney / liver eligibility criteria:
Inclusion Criteria:
Exclusion Criteria:
Recipient eligibility criteria:
Inclusion Criteria:
Exclusion criteria:
Patient recipient will not be included if any of the following conditions exists:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalario Universitario A Coruña (CHUAC) | A Coruña | 15006 | Spain |
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| within 30 days post-transplant |
| Evaluation of patient anxiety (Kidney & Liver) | The patient will complete the HAD scale ("Hospital Anxiety and Depression Scale") after signing his/her consent before the transplant. | pre-transplant |
| Duration of delayed graft function (Kidney) | within 30 days post-transplant |
| Rate of functional delayed graft function (f-DGF) (Kidney) | within 7 days post-transplant |
| Daily serum creatinine (Kidney) | 7 days post-transplant, or until the patient is discharged - whichever is earliest |
| Peak level of serum AST (Liver) | within 7 days post-transplant |
| Post-reperfusion syndrome (Liver) | during operative procedure |