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

Hopital Foch

Status: Active, not recruiting

Conditions: Lung Diseases; Transplant-Related Disorder

Treatments: Other: Control; Other: Quantra

Study type: Interventional

Funder types: Other

Identifiers

NCT05798286

2020_0084

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

QUANTRA group

Experimental group

Description:

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.

Treatment:

Other: Quantra

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Control