Clinical trial NCT05798286: Quantra® System With the QPlus® Cartridge in Double-lung Transplantation
Official title: Does Bedside Ultrasound Clot Elasticity Measurement Reduce Intraoperative Transfusion During Double-lung Transplantation?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Diseases
Transplant-Related Disorder
Keywords: Resonance sonorheometry
Viscoelastic testing
Quantra system
Lung transplantation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel group
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Labile blood products measure
timeFrame: 24 hours
Secondary outcomes:
measure: The impact of Quantra® on the administration of each type of transfusion during surgery and within 24 hours after transplantation
timeFrame: 24 hours
measure: blood loss during surgery
timeFrame: 24 hours
measure: The occurrence of acute primary graft dysfunction at day 3.
timeFrame: 3 days
measure: 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
timeFrame: 6 months
measure: Hospital mortality, at 30 days, 90 days, and 12 months
timeFrame: 12 months
measure: Number of transfused labile blood products during the length of an individual's stay in hospital
timeFrame: up to 12 months
measure: Duration of stay in intensive care
timeFrame: up to 12 months
measure: The median cost of transfused labile blood products
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Foch Hospital
name: Julien Fessler, MD
role: STUDY_DIRECTOR
affiliation: Foch Hospital
name: Tiffany Pascreau, MD
role: PRINCIPAL_INVESTIGATOR
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