Hemorrhage, Surgical, Liver Transplant
Conditions
Brief summary
Intraoperative cell salvage is commonly used in surgeries that carry a major hemorrhagic risk to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation status after these types of surgeries, especially liver transplantation. There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population. The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.
Detailed description
\- Study design: Randomized controlled bi-center trial * Primary objective: to compare platelet number and function after processing and re-transfusion of the salvaged blood to the patient by using different cell saver devices. * Secondary (main) objectives: to compare a) the coagulation profile and b) the usage of blood products (frequency of administration of labile and stable blood products).
Interventions
DEVICECell Salvage Autotransfusion: SAME™ device
* Intervention studied: processing of salvaged blood using the SAME™ autotransfusion device * Population studied: 20 patients planned to undergo high-risk liver transplantation. * Treatment group. All perioperative measures will be performed according to international, national and in-house standards.
DEVICECell Salvage Autotransfusion: Autolog™ device
* Intervention studied: processing of salvaged blood using the Autolog™ (Medtronic) autotransfusion device (in-house standard device). * Population studied: 20 patients planned to undergo high-risk liver transplantation. * Control group All perioperative measures will be performed according to international, national and in-house standards.
Sponsors
University Hospital, Geneva
Insel Gruppe AG, University Hospital Bern
Eduardo Schiffer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All adult patients undergoing liver transplantation surgery
Exclusion criteria
* Age \< 18 years old * Active liver malignancy * Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin) * Inability to understand and sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet number | Day 1 | Platelet number will be measured using flow cytometry in the laboratory after processing and after retransfusion of the salvaged blood to the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood plasma albumin level | Day 1 | measured by spectrophotometry |
| Blood hemoglobin level | Day 1 | measured by spectrophotometry |
| Blood lactate level | Day 1 | measured by spectrophotometry |
| Free hemoglobin level | Day 1 | measured by spectrophotometry |
| Platelet function | Day 1 | Platelets function will be assessed by multiple electrode aggregometry (Multiplate® analyzer, Roche Diagnostics, Mannheim, Germany). |
| Number of allogeneic blood products used | Day 1 | Number of allogeneic blood products used (red blood cell, fresh frozen plasma, platelet concentrates) until ICU discharge |
| Number of coagulation concentrates used | Day 1 | Number of coagulation concentrates used (prothrombin complex concentrate, fibrinogen concentrate) until ICU discharge |
| Amount of autologous blood at the end of the liver transplantation | Day 1 | Amount of autologous blood at the end of the liver transplantation |
| Anti-Xa activity | Day 1 | measured by Anti-Xa assay |
Countries
Switzerland
Contacts
Primary ContactEduardo Schiffer, MD
Backup ContactTony Mouawad, MD
Outcome results
None listed