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Completed

NCT Number: NCT05798286

Quantra® System With the QPlus® Cartridge in 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.

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases Transplant-Related Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foch Hospital

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantra

Other

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

Control

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. blood loss during surgery

    Time frame: 24 hours

    volume of blood lost during surgery.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: QUANTRANS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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