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

June 13, 2024 updated by: Hopital Foch

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Suresnes, France, 92150
        • Recruiting
        • Foch Hospital
        • Contact:
          • Julien Fessler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QUANTRA group

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
The study plans to collect 2 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts.
Active Comparator: Control group

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labile blood products measure
Time Frame: 24 hours
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
Time Frame: 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
24 hours
blood loss during surgery
Time Frame: 24 hours
volume of blood lost during surgery.
24 hours
The occurrence of acute primary graft dysfunction at day 3.
Time Frame: 3 days
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
Time Frame: 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.
6 months
Hospital mortality, at 30 days, 90 days, and 12 months
Time Frame: 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
Time Frame: up to 12 months
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
Time Frame: up to 12 months
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
Time Frame: up to 12 months
The median cost of transfused labile blood products will evaluated during the length of an individual's stay in hospital
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Study Director: Julien Fessler, MD, Foch Hospital
  • Principal Investigator: Tiffany Pascreau, MD, Foch Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_0084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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