Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06749405
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2024-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of a Quantra-guided Transfusion Algorithm in Liver Transplantation
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Assessment of a Quantra-guided Transfusion Algorithm in Liver Transplantation
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUALIVERT
Brief Summary:
Liver transplantation carries a substantial risk of bleeding, making precise haemostasis control essential, although assessing coagulation remains challenging. Quantra, a bedside viscoelastic testing device using sonorheometric methods, offers an innovative approach to guiding haemostatic management during surgery. The study aims to determine whether a Quantra-guided transfusion can reduce transfusion and bleeding during liver transplantation when compared to a conventional transfusion approach.
Detailed Description:
Liver orthotopic transplantation (LT) represents the best treatment option for patients with end-stage liver disease (ESLD), as well as for various oncological, metabolic, and genetic indications. In the setting of ESLD, particularly when decompensated, LT is associated with a substantial risk of bleeding, making the assessment of coagulation and haemostasis management challenging. ESLD is characterized by a fragile balance between pro- and anti-coagulant factors, where routine coagulation tests are often altered but poorly correlated with the risk of bleeding. Additionally, the presence of portal hypertension with venous collaterals and previous abdominal surgeries significantly increase surgical risk. Many intraoperative events, such as acidosis, hypocalcaemia, consumptive coagulopathy, haemodilution, or post-reperfusion hyperfibrinolysis are also likely to induce or exacerbate bleeding. These factors highlight the challenges anaesthesiologists face when guiding haemostatic management during LT. A transfusion strategy based on routine coagulation tests is widely questioned. These tests provide an imperfect reflection of clot formation in cirrhotic patients, fail to assess haemostasis comprehensively, and do not consider the coagulation-anticoagulation balance. Moreover, the minimum delay in obtaining biological results (typically around 30 to 60 minutes), complicates this therapeutic approach, particularly in bleeding emergencies, when the biological findings no longer fully reflect the clinical situation at the time of receiving the results.
Viscoelastic tests (VETs) offer a better understanding of haemostatic capacity and can guide the transfusion of labile blood products. VETs dynamically evaluate clot formation, encompassing processes from platelet activation to fibrinolysis. As rapid functional assays, they pinpoint the specific disruptions in the coagulation process and assist clinicians to determine the most appropriate haemostatic intervention. Several studies have demonstrated that implementing VET-guided transfusion algorithms in LT can reducethe use of therapeutic plasma and red blood cell concentrates, potentially decreasing perioperative bleeding. Despite these advantages, the routine adoption of VETS in clinical practice faces significant technical challenges, particularly in the management of pre-analytical and analytical phases, as well as in the interpretation of result.
The Quantra® (Stago BioCare) is a next-generation coagulation monitoring device that assesses the viscoelastic properties of clot formation through sonorheometry. By avoiding mechanical contact, it offers an innovative approach with high sensitivity to weak clots, particularly in cases of hypofibrinogenemia or thrombocytopenia. and its use is simplified by ready-to-use cartridges. However, the clinical relevance of a Quantra®-based transfusion algorithm in LT-specifically for transfusion reduction and bleeding management-has yet to be demonstrated.
Viscoelastic tests (VETs) offer a better understanding of haemostatic capacity and can guide the transfusion of labile blood products. VETs dynamically evaluate clot formation, encompassing processes from platelet activation to fibrinolysis. As rapid functional assays, they pinpoint the specific disruptions in the coagulation process and assist clinicians to determine the most appropriate haemostatic intervention. Several studies have demonstrated that implementing VET-guided transfusion algorithms in LT can reducethe use of therapeutic plasma and red blood cell concentrates, potentially decreasing perioperative bleeding. Despite these advantages, the routine adoption of VETS in clinical practice faces significant technical challenges, particularly in the management of pre-analytical and analytical phases, as well as in the interpretation of result.
The Quantra® (Stago BioCare) is a next-generation coagulation monitoring device that assesses the viscoelastic properties of clot formation through sonorheometry. By avoiding mechanical contact, it offers an innovative approach with high sensitivity to weak clots, particularly in cases of hypofibrinogenemia or thrombocytopenia. and its use is simplified by ready-to-use cartridges. However, the clinical relevance of a Quantra®-based transfusion algorithm in LT-specifically for transfusion reduction and bleeding management-has yet to be demonstrated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A00944-43 | OTHER | Agence National de Sécurité du Médicament | View |