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

Not Applicable

Recruiting

• Conditions: Transplant-Related Disorder; Lung Diseases
• Interventions: Other: Control; Other: Quantra

• Registration Number: NCT05798286
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-04
• Study Start: 2023-05-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-12-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	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.
QUANTRA group	Quantra	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.

Primary Outcome Measures

Name	Time	Method
Labile blood products measure	24 hours	Number of labile blood products (red blood cells pack + fresh frozen plasma) transfused in the operating room.

Secondary Outcome Measures

Name	Time	Method
The impact of Quantra® on the administration of each type of transfusion during surgery and within 24 hours after transplantation	24 hours	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
blood loss during surgery	24 hours	volume of blood lost during surgery.
Hospital mortality, at 30 days, 90 days, and 12 months	12 months	Hospital mortality rate, at 30 days, 90 days, and at 12 months.
Duration of stay in intensive care	up to 12 months	The duration of stay in intensive care will evaluated during the length of an individual's stay in hospital
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	6 months	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.
Number of transfused labile blood products during the length of an individual's stay in hospital	up to 12 months	The number of transfused labile blood products will evaluated during the length of an individual's stay in hospital
The median cost of transfused labile blood products	up to 12 months	The median cost of transfused labile blood products will evaluated during the length of an individual's stay in hospital
The occurrence of acute primary graft dysfunction at day 3.	3 days	Grade 3 primary graft dysfunction measured on the 3rd postoperative day

Trial Locations

Locations (1)

Foch Hospital; 🇫🇷 Suresnes, France