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| Name | Class |
|---|---|
| Laboratoire français de Fractionnement et de Biotechnologies | INDUSTRY |
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In current practice, management of coagulation during liver transplantation is performed either through standard coagulation status or with ROTEM® depending on practitioner choice and availability of materials. In this context, the ROTEM® is used since over 2 years by anesthesiologists in the digestive surgery department of the Croix Rousse hospital in Lyon, France.
Indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy developed by patients who are eligible, due to coagulation factor synthesis deficiencies in the cirrhotic liver. On the other hand the standard coagulation profile is a poor reflection of coagulopathy in such patients because the imbalance between pro- and anti-coagulant factors are not taken into account by PT and aPTT measures. Management of intraoperative hemorrhage may be facilitated by the ROTEM® which is performed from whole blood and which allows the detection of abnormalities in the balance between pro- and anti-coagulant factors.
This technique was already evaluated in liver, cardiac, and obstetric surgery but also in traumatology. Randomized trials in liver transplantation surgery have shown changes in transfusion practices but did not focus on the consequences of such changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S group | Placebo Comparator | S Group: will be transfused patients according to standard management based on conventional coagulation profile of the laboratory |
|
| R group | Experimental | The R group will consist of patients transfused according to an algorithm based on the data of the coagulation ROTEM analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional coagulation profile Analysis | Procedure | Transfusional protocol for Standard group Red Blood cells concentrate if Hemoglobin <9 gram per liter Fibrinogen 3 gram, if fibrinogen <1gram per liter Platelet concentrate :
Analyses common to both groups: NFS, chemistry panel with ionized serum calcium, blood gas with lactates, HemoCue ®, capillary blood glucose. Analyses in S Group only: coagulation profile (PT, APTT, INR, fibrinogen, platelet count, soluble complexes, PDF). |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of blood product (in milliliter) transfused during liver transplantation. | Assessing the impact of intraoperative management of coagulation by ROTEM® compared to the conventional management (standard coagulation profile) on the amount of blood product units (in milliliter) transfused during liver transplantation. | During time of liver transplantation an average of 9 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of serious respiratory complication. | reintubation; acute pulmonary oedema. | within 48 first hours after liver transplantation. |
| Occurrence of thrombotic complication. | hepatic artery thrombosis, sus hepatic thrombotic, portal thrombosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurélie Bonnet, PH | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Rousse | Lyon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31567574 | Result | Bonnet A, Gilquin N, Steer N, Gazon M, Quattrone D, Pradat P, Maynard M, Mabrut JY, Aubrun F. The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study. Eur J Anaesthesiol. 2019 Nov;36(11):825-833. doi: 10.1097/EJA.0000000000001084. |
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| Rotem analysis | Procedure | Transfusional protocol for Rotem group. Red Blood cells concentrate if Hemoglobin <9 gram per liter Fibrinogen 3 gram, if A10 FIBTEM <8 mm Platelet concentrate :
Bolus Tranexamic acid 1g and 3g every 24 hours :
Analyses in R group only: blood sampling on citrated tube for ROTEM analysis (EXTEM, INTEM, FIBTEM, APTEM +/- HEPTEM), coagulation profile (same as that of the S Group, for emergency procedure). Analyses common to both groups: NFS, chemistry panel with ionized serum calcium, blood gas with lactates, HemoCue ®, capillary blood glucose. |
|
| within 48 first hours after liver transplantation. |
| Occurrence of serious infectious complication | septic shock; serious sepsis, intubation necessity for sepsis. | within 48 first hours after liver transplantation. |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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