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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
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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.
- Study design: Randomized controlled bi-center trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAME™ Device group | Experimental | SAME™ Autotransfusion Device that is being tested for recovery of platelets along with RBCs |
|
| Autolog™ Device group | Active Comparator | Autolog™ standard autotransfusion device currently used at our institution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell Salvage Autotransfusion: SAME™ device | Device |
All perioperative measures will be performed according to international, national and in-house standards. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet number | Platelet number will be measured using flow cytometry in the laboratory after processing and after retransfusion of the salvaged blood to the patient. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet function | Platelets function will be assessed by multiple electrode aggregometry (Multiplate® analyzer, Roche Diagnostics, Mannheim, Germany). | Day 1 |
| Platelet function | Platelets function will be measured by platelet activation markers (P-selectin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Schiffer, MD | Contact | +41 22 372 3060 | eduardo.schiffer@hcuge.ch | |
| Tony Mouawad, MD | Contact | +41 79 553 2117 | tony.mouawad@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Eduardo Schiffer, MD | University Hospital, Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37294939 | Background | Mansour A, Beurton A, Godier A, Rozec B, Zlotnik D, Nedelec F, Gaussem P, Fiore M, Boissier E, Nesseler N, Ouattara A. Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study). Anesthesiology. 2023 Sep 1;139(3):287-297. doi: 10.1097/ALN.0000000000004642. | |
| 33984126 |
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|
| Cell Salvage Autotransfusion: Autolog™ device | Device |
All perioperative measures will be performed according to international, national and in-house standards. |
|
| Day 1 |
| Platelet function | Platelets function will be measured by platelet activation markers (GPIb) | Day 1 |
| Platelet function | Platelets function will be measured by platelet activation markers (GPIIb) | Day 1 |
| Platelet function | Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using ExTest. | Day 1 |
| Platelet function | Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using FibTest assays. | Day 1 |
| Blood plasma albumin level | measured by spectrophotometry | Day 1 |
| Blood hemoglobin level | measured by spectrophotometry | Day 1 |
| Blood lactate level | measured by spectrophotometry | Day 1 |
| Free hemoglobin level | measured by spectrophotometry | Day 1 |
| Anti-Xa activity | measured by Anti-Xa assay | Day 1 |
| Number of allogeneic blood products used | Number of allogeneic blood products used (red blood cell, fresh frozen plasma, platelet concentrates) until ICU discharge | Day 1 |
| Number of coagulation concentrates used | Number of coagulation concentrates used (prothrombin complex concentrate, fibrinogen concentrate) until ICU discharge | Day 1 |
| Amount of autologous blood at the end of the liver transplantation | Amount of autologous blood at the end of the liver transplantation | Day 1 |
| Background |
| Mansour A, Decouture B, Roussel M, Lefevre C, Skreko L, Picard V, Ouattara A, Bachelot-Loza C, Gaussem P, Nesseler N, Gouin-Thibault I. Combined Platelet and Erythrocyte Salvage: Evaluation of a New Filtration-based Autotransfusion Device. Anesthesiology. 2021 Aug 1;135(2):246-257. doi: 10.1097/ALN.0000000000003820. |
| 29989144 | Background | Klein AA, Bailey CR, Charlton AJ, Evans E, Guckian-Fisher M, McCrossan R, Nimmo AF, Payne S, Shreeve K, Smith J, Torella F. Association of Anaesthetists guidelines: cell salvage for peri-operative blood conservation 2018. Anaesthesia. 2018 Sep;73(9):1141-1150. doi: 10.1111/anae.14331. Epub 2018 Jul 10. |
| 28580663 | Background | Sikorski RA, Rizkalla NA, Yang WW, Frank SM. Autologous blood salvage in the era of patient blood management. Vox Sang. 2017 Aug;112(6):499-510. doi: 10.1111/vox.12527. Epub 2017 Jun 5. |
| 35324911 | Background | Schreiber K, Decouture B, Lafragette A, Chollet S, Bruneau M, Nicollet M, Wittmann C, Gadrat F, Mansour A, Forest-Villegas P, Gauthier O, Touzot-Jourde G. A novel autotransfusion device saving erythrocytes and platelets used in a 72 h survival swine model of surgically induced controlled blood loss. PLoS One. 2022 Mar 24;17(3):e0260855. doi: 10.1371/journal.pone.0260855. eCollection 2022. |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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