Liver TransplantationQUALIVERTNCT06749405
Assessment of a Quantra-guided Transfusion Algorithm in Liver Transplantation
A study testing Transfusion algorithm based on Quantra® and Conventional transfusion algorithm in people with Liver Transplantation, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Transfusion algorithm based on Quantra® and Conventional transfusion algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Patient with ESLD undergoing liver transplantation
- Individuals affiliated with or beneficiaries of a social security scheme
- Free and informed written consent obtained in writing from the patient, or where applicable from the trusted person/family member/close relative
- Non-inclusion Criteria:
- Multi-organ transplantation
Show all 10Show fewer
- Congenital haemostasis disorder (such as haemophilia)
- Patient under juridical protection (persons deprived of liberty or under curatorship or guardianship or safeguard of justice)
- Pregnant or breast-feeding woman
- Patient already enrolled in another interventional study with primary or secondary objective of reducing perioperative bleeding or transfusion
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Toulouse University Hospital
Toulouse, 31059
Guillaume PORTA BONETE, 5 61 32 35 65 ext. +33, porta-bonete.g@chu-toulouse.fr
Guillaume PORTA BONETE
About this study
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.
Read the 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.
- Conditions
- Liver Transplantation
- Being tested
- Transfusion algorithm based on Quantra®, Conventional transfusion algorithm
- Keywords
- Liver transplantation, Bleeding, Blood transfusion, Quantra®, Viscoelastic test, Haemorrhagic surgery, Labile blood products, Randomized controlled trial, Coagulation, End-stage liver disease (ESLD)
- Medical subject headings
- Hemorrhage, Thrombosis, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion algorithm based on Quantra®Biological
In addition to routine coagulation tests, a Quantra Qstat® analysis will be performed at baseline (before incision), at the end of native liver dissection, and after unclamping of the venous anastomoses. In the event of bleeding, additional Quantra Qstat® analyses may be conducted until bleeding control is achieved.
Transfusion and administration of blood-derived medications will be guided by the results of the Quantra Qstat® analyses.
Conventional transfusion algorithmBiological
Transfusion and blood-derived medications will be guided by the results of routine coagulation tests.
| Study group | Role | What they receive |
|---|---|---|
| Transfusion algorithm based on Quantra® | Experimental | Patients managed using a transfusion algorithm based on Quantra®. Receives: Biological: Transfusion algorithm based on Quantra® |
| Conventional transfusion algorithm | Active comparator | Patients managed using a conventional transfusion algorithm. Receives: Biological: Conventional transfusion algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fresh Frozen Plasma (FFP) transfusion during liver transplantation surgery
Number of FFP transfused intraoperatively during liver transplantation surgery.
Measured: Conducted during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start8 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Intervention Group: Patients managed using a transfusion algorithm based on Quantra® * Control Group: Patients managed using a conventional transfusion algorithm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume PORTA BONETE, Md, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749405
- Sponsor's protocol ID
- RC31/23/0621
- Other IDs
- 2024-A00944-43
- Acronym
- QUALIVERT
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Quantra-guided Transfusion Algorithm in Liver Transplantation
- ClinicalTrials.gov ID
- NCT06749405
- Acronym / sponsor ID
- QUALIVERT / RC31/23/0621
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, Bleeding, Blood transfusion, Quantra®, Viscoelastic test, Haemorrhagic surgery, Labile blood products, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * Intervention Group: Patients managed using a transfusion algorithm based on Quantra® * Control Group: Patients managed using a conventional transfusion algorithm
| Arm | Type | Receives |
|---|---|---|
| Transfusion algorithm based on Quantra® | Experimental | Biological: Transfusion algorithm based on Quantra®Patients managed using a transfusion algorithm based on Quantra®. |
| Conventional transfusion algorithm | Active comparator | Biological: Conventional transfusion algorithmPatients managed using a conventional transfusion algorithm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 18 years or older
- Patient with ESLD undergoing liver transplantation
- Individuals affiliated with or beneficiaries of a social security scheme
- Free and informed written consent obtained in writing from the patient, or where applicable from the trusted person/family member/close relative
- Multi-organ transplantation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfusion algorithm based on Quantra®In addition to routine coagulation tests, a Quantra Qstat® analysis will be performed at baseline (before incision), at the end of native liver dissection, and after unclamping of the venous anastomoses. In the event of bleeding, additional Quantra Qstat® analyses may be conducted until bleeding control is achieved. Transfusion and administration of blood-derived medications will be guided by the results of the Quantra Qstat® analyses. | Biological | Transfusion algorithm based on Quantra® |
| Conventional transfusion algorithmTransfusion and blood-derived medications will be guided by the results of routine coagulation tests. | Biological | Conventional transfusion algorithm |
Primary outcome
Fresh Frozen Plasma (FFP) transfusion during liver transplantation surgery
Time frame: Conducted during surgery
Number of FFP transfused intraoperatively during liver transplantation surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume PORTA BONETE, Md principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfusion algorithm based on Quantra® and Conventional transfusion algorithm in people with Liver Transplantation, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume PORTA BONETE, Md (561323565 ext. +33, porta-bonete.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fresh Frozen Plasma (FFP) transfusion during liver transplantation surgery (time frame: Conducted during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.