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

Primary Purpose

Lung Diseases, Transplant-Related Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quantra
Control
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases focused on measuring Resonance sonorheometry, Viscoelastic testing, Quantra system, Lung transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Foch HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QUANTRA group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
blood loss during surgery
volume of blood lost during surgery.
The occurrence of acute primary graft dysfunction at day 3.
Grade 3 primary graft dysfunction measured on the 3rd postoperative day
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.
Hospital mortality, at 30 days, 90 days, and 12 months
Hospital mortality rate, at 30 days, 90 days, and at 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
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
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

Full Information

First Posted
March 16, 2023
Last Updated
June 13, 2023
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT05798286
Brief Title
Quantra® System With the QPlus® Cartridge in Double-lung Transplantation
Acronym
QUANTRANS
Official Title
Does Bedside Ultrasound Clot Elasticity Measurement Reduce Intraoperative Transfusion During Double-lung Transplantation?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Transplant-Related Disorder
Keywords
Resonance sonorheometry, Viscoelastic testing, Quantra system, Lung transplantation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Parallel group
Masking
Participant
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QUANTRA group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Quantra
Intervention Description
The study plans to collect 2 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Labile blood products measure
Description
Number of labile blood products (red blood cells pack + fresh frozen plasma) transfused in the operating room.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The impact of Quantra® on the administration of each type of transfusion during surgery and within 24 hours after transplantation
Description
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
Time Frame
24 hours
Title
blood loss during surgery
Description
volume of blood lost during surgery.
Time Frame
24 hours
Title
The occurrence of acute primary graft dysfunction at day 3.
Description
Grade 3 primary graft dysfunction measured on the 3rd postoperative day
Time Frame
3 days
Title
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
Description
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.
Time Frame
6 months
Title
Hospital mortality, at 30 days, 90 days, and 12 months
Description
Hospital mortality rate, at 30 days, 90 days, and at 12 months.
Time Frame
12 months
Title
Number of transfused labile blood products during the length of an individual's stay in hospital
Description
The number of transfused labile blood products will evaluated during the length of an individual's stay in hospital
Time Frame
up to 12 months
Title
Duration of stay in intensive care
Description
The duration of stay in intensive care will evaluated during the length of an individual's stay in hospital
Time Frame
up to 12 months
Title
The median cost of transfused labile blood products
Description
The median cost of transfused labile blood products will evaluated during the length of an individual's stay in hospital
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marjolaine Ngollo, PhD
Phone
01 46 25 37 49
Ext
+33
Email
m.ngollo-nsoh@hopital-foch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar Sellami, PhD
Phone
01 46 25 31 37
Ext
+33
Email
s.sellami-jallouli@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Fessler, MD
Organizational Affiliation
Foch Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tiffany Pascreau, MD
Organizational Affiliation
Foch Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foch Hospital
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Fessler, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Quantra® System With the QPlus® Cartridge in Double-lung Transplantation

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