Quantra® System With the QPlus® Cartridge in Double-lung Transplantation

Study Overview
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Brief Summary
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Transfusion in lung transplantation is common, and despite improved techniques and limitations in the use of mechanical circulatory support (MCS), the incidence of massive transfusion has remained stable over the years. The consequences of blood transfusion (blood cells, plasma, platelet concentrates) are deleterious for patients and increase primary graft dysfunction and mortality risk. Whole blood viscoelastic testing devices have shown its effectiveness in monitoring coagulation and fibrinolytic function during cardiac surgery, liver transplantation or trauma. So far, few delocalized biology tools have been evaluated in lung transplantation. The main objective of this study is to determine if the use of a transfusion algorithm based on whole blood viscoelastic test with Quantra® test reduce transfusion during lung transplantation.

Official Title
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Does Bedside Ultrasound Clot Elasticity Measurement Reduce Intraoperative Transfusion During Double-lung Transplantation?

Conditions
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Lung Diseases, Transplant-Related Disorder

Intervention / Treatment
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* Other: Quantra
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing double-lung transplantation Patient is ≥ 18 years-old Patient is willing to participate, and is willing to consent Patient affiliated to a national health insurance Exclusion Criteria: Patient is younger than 18 years-old Patient with an indication for non double-lung transplantation Patient under extracorporeal membrane oxygenation in bridge to transplantation Patient with surgery under cardiopulmonary bypass Patient benefiting from a multi-organ transplantation Patient being deprived of liberty or under guardianship Patient refusing to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Parallel group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QUANTRA group<br>Adult subjects (18 years-old or older) undergoing double-lung transplantation: transfusion algorithm based on whole blood viscoelastic test with Quantra® + standard coagulation test. These samples are collected at five standard surgical time points: on arrival at the hospital on the day of surgery, after first pulmonary artery clamping, after first graft implantation, after second graft implantation, at end-surgery status. | Other: Quantra<br>* The study plans to collect 2 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts.<br>|
| Active Comparator: Control group<br>Adult subjects (18 years-old or older) undergoing double-lung transplantation: standard transfusion algorithm based on standard practice and coagulation test. These samples are collected at five standard surgical time points: on arrival at the hospital on the day of surgery, after first pulmonary artery clamping, after first graft implantation, after second graft implantation, at end-surgery status. | Other: Control<br>* The study plans to collect 1 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts at each time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labile blood products measure | Number of labile blood products (red blood cells pack + fresh frozen plasma) transfused in the operating room. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of Quantra® on the administration of each type of transfusion during surgery and within 24 hours after transplantation | Number of patients receiving each type of labile blood product and the number of red blood cell pack, platelet concentrates, fresh frozen plasma, and fibrinogen administered during surgery and within 24 hours following surgery | 24 hours | 
| blood loss during surgery | volume of blood lost during surgery. | 24 hours | 
| The occurrence of acute primary graft dysfunction at day 3. | Grade 3 primary graft dysfunction measured on the 3rd postoperative day | 3 days | 
| Quality of life six months after surgery using EQ-5D-5L questionnaire including five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression | Quality of life questionnaire assement using the EuroQol Group's five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) including five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | 6 months | 
| Hospital mortality, at 30 days, 90 days, and 12 months | Hospital mortality rate, at 30 days, 90 days, and at 12 months. | 12 months | 
| Number of transfused labile blood products during the length of an individual's stay in hospital | The number of transfused labile blood products will evaluated during the length of an individual's stay in hospital | up to 12 months | 
| Duration of stay in intensive care | The duration of stay in intensive care will evaluated during the length of an individual's stay in hospital | up to 12 months | 
| The median cost of transfused labile blood products | The median cost of transfused labile blood products will evaluated during the length of an individual's stay in hospital | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resonance sonorheometry, Viscoelastic testing, Quantra system, Lung transplantation