Lung DiseasesQUANTRANSNCT05798286
Quantra® System With the QPlus® Cartridge in Double-lung Transplantation
A study testing Quantra in people with Lung Diseases and Transplant-Related Disorder, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Transplant-Related Disorder
- What is being tested?
- Quantra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2023to 2 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Diseases, Transplant-Related Disorder
- Being tested
- Quantra, Control
- Keywords
- Resonance sonorheometry, Viscoelastic testing, Quantra system, Lung transplantation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuantraOther
The study plans to collect 2 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| QUANTRA group | Experimental | 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. Receives: Other: Quantra |
| Control group | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labile blood products measure
Number of labile blood products (red blood cells pack + fresh frozen plasma) transfused in the operating room.
Measured: 24 hours
Secondary outcomes (8)
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
Measured: 24 hours
blood loss during surgery
volume of blood lost during surgery.
Measured: 24 hours
The occurrence of acute primary graft dysfunction at day 3.
Grade 3 primary graft dysfunction measured on the 3rd postoperative day
Measured: 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
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.
Measured: 6 months
Hospital mortality, at 30 days, 90 days, and 12 months
Hospital mortality rate, at 30 days, 90 days, and at 12 months.
Measured: 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
Measured: up to 12 months
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
Measured: up to 12 months
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
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 May 2023
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Fessler, MD, Study director, Foch HospitalTiffany Pascreau, MD, Principal investigator, Foch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798286
- Sponsor's protocol ID
- 2020_0084
- Acronym
- QUANTRANS
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herrington CS, Prekker ME, Arrington AK, Susanto D, Baltzell JW, Studenski LL, Radosevich DM, Kelly RF, Shumway SJ, Hertz MI, Bittner HB, Dahlberg PS. A randomized, placebo-controlled trial of aprotinin to reduce primary graft dysfunction following lung transplantation. Clin Transplant. 2011 Jan-Feb;25(1):90-6. doi: 10.1111/j.1399-0012.2010.01319.x. Epub 2010 Aug 19.
PubMed 20731686Triulzi DJ, Griffith BP. Blood usage in lung transplantation. Transfusion. 1998 Jan;38(1):12-5. doi: 10.1046/j.1537-2995.1998.38198141492.x.
PubMed 9482388Cernak V, Oude Lansink-Hartgring A, van den Heuvel ER, Verschuuren EAM, van der Bij W, Scheeren TWL, Engels GE, de Geus AF, Erasmus ME, de Vries AJ. Incidence of Massive Transfusion and Overall Transfusion Requirements During Lung Transplantation Over a 25-Year Period. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2478-2486. doi: 10.1053/j.jvca.2019.03.060. Epub 2019 Mar 30.
PubMed 31147209Huddleston SJ, Jackson S, Kane K, Lemke N, Shaffer AW, Soule M, Hertz M, Shumway S, Qi S, Perry T, Kelly R. Separate Effect of Perioperative Recombinant Human Factor VIIa Administration and Packed Red Blood Cell Transfusions on Midterm Survival in Lung Transplantation Recipients. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3013-3020. doi: 10.1053/j.jvca.2020.05.038. Epub 2020 Jun 3.
PubMed 32718888Seay T, Guinn N, Maisonave Y, Fuller M, Poisson J, Pollak A, Bryner B, Haney J, Klapper J, Hartwig M, Bottiger B. The Association of Increased FFP:RBC Transfusion Ratio to Primary Graft Dysfunction in Bleeding Lung Transplantation Patients. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3024-3032. doi: 10.1053/j.jvca.2020.05.043. Epub 2020 Jun 7.
PubMed 32622711Cimic N, Tulleken JE, Zijlstra JG, van der Bij W, Boonstra PW. Recombinant factor VIIa for refractory hemorrhage after lung transplantation. Transplantation. 2005 Mar 27;79(6):741-2. doi: 10.1097/01.tp.0000147319.66838.71. No abstract available.
PubMed 15785389Felten ML, Fischler M. Intraoperative use of activated recombinant factor VII for refractory bleeding in complicated lung transplantations. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):382-3. doi: 10.1053/j.jvca.2009.06.006. Epub 2009 Aug 19. No abstract available.
PubMed 19695905Detterbeck FC, Egan TM, Mill MR. Lung transplantation after previous thoracic surgical procedures. Ann Thorac Surg. 1995 Jul;60(1):139-43.
PubMed 7598576Ius F, Kuehn C, Tudorache I, Sommer W, Avsar M, Boethig D, Fuehner T, Gottlieb J, Hoeper M, Haverich A, Warnecke G. Lung transplantation on cardiopulmonary support: venoarterial extracorporeal membrane oxygenation outperformed cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1510-6. doi: 10.1016/j.jtcvs.2012.07.095. Epub 2012 Aug 31.
PubMed 22944092Hoechter DJ, Shen YM, Kammerer T, Gunther S, Weig T, Schramm R, Hagl C, Born F, Meiser B, Preissler G, Winter H, Czerner S, Zwissler B, Mansmann UU, von Dossow V. Extracorporeal Circulation During Lung Transplantation Procedures: A Meta-Analysis. ASAIO J. 2017 Sep/Oct;63(5):551-561. doi: 10.1097/MAT.0000000000000549.
PubMed 28257296Adelmann D, Koch S, Menger J, Opfermann P, Jaksch P, Hoetzenecker K, Kurz M, Mouhieddine M, Steinlechner B. Risk factors for early bleeding complications after lung transplantation - a retrospective cohort study. Transpl Int. 2019 Dec;32(12):1313-1321. doi: 10.1111/tri.13491. Epub 2019 Aug 30.
PubMed 31402529Kesten S, de Hoyas A, Chaparro C, Westney G, Winton T, Maurer JR. Aprotinin reduces blood loss in lung transplant recipients. Ann Thorac Surg. 1995 Apr;59(4):877-9. doi: 10.1016/0003-4975(95)00051-l.
PubMed 7535041Balsara KR, Morozowich ST, Lin SS, Davis RD, Phillips-Bute BG, Hartwig M, Appel JZ, Welsby IJ. Aprotinin's effect on blood product transfusion in off-pump bilateral lung transplantation. Interact Cardiovasc Thorac Surg. 2009 Jan;8(1):45-8. doi: 10.1510/icvts.2008.178749. Epub 2008 Jul 31.
PubMed 18669527Bittner HB, Richter M, Kuntze T, Rahmel A, Dahlberg P, Hertz M, Mohr FW. Aprotinin decreases reperfusion injury and allograft dysfunction in clinical lung transplantation. Eur J Cardiothorac Surg. 2006 Feb;29(2):210-5. doi: 10.1016/j.ejcts.2005.12.001.
PubMed 16386921Bittner HB, Binner C, Dahlberg P, Mohr FW. Reducing ischemia-reperfusion injury in clinical lung transplantation. Transplant Proc. 2007 Mar;39(2):489-92. doi: 10.1016/j.transproceed.2006.12.005.
PubMed 17362765
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Bedside Ultrasound Clot Elasticity Measurement Reduce Intraoperative Transfusion During Double-lung Transplantation?
- ClinicalTrials.gov ID
- NCT05798286
- Acronym / sponsor ID
- QUANTRANS / 2020_0084
- Conditions
- Lung Diseases, Transplant-Related Disorder
- Keywords
- Resonance sonorheometry, Viscoelastic testing, Quantra system, Lung transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, Parallel group
| Arm | Type | Receives |
|---|---|---|
| QUANTRA group | Experimental | Other: QuantraAdult 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. |
| Control group | Active comparator | Other: ControlAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuantraThe study plans to collect 2 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts. | Other | QUANTRA group |
| ControlThe study plans to collect 1 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts at each time. | Other | Control group |
Primary outcome
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.
8 secondary outcomes
The impact of Quantra® on the administration of each type of transfusion during surgery and within 24 hours after transplantation
Time frame: 24 hours
blood loss during surgery
Time frame: 24 hours
The occurrence of acute primary graft dysfunction at day 3.
Time frame: 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
Hospital mortality, at 30 days, 90 days, and 12 months
Time frame: 12 months
Number of transfused labile blood products during the length of an individual's stay in hospital
Time frame: up to 12 months
Duration of stay in intensive care
Time frame: up to 12 months
The median cost of transfused labile blood products
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 20731686Herrington CS, Prekker ME, Arrington AK, Susanto D, Baltzell JW, Studenski LL, Radosevich DM, Kelly RF, Shumway SJ, Hertz MI, Bittner HB, Dahlberg PS. A randomized, placebo-controlled trial of aprotinin to reduce primary graft dysfunction following lung transplantation. Clin Transplant. 2011 Jan-Feb;25(1):90-6. doi: 10.1111/j.1399-0012.2010.01319.x. Epub 2010 Aug 19.
- Results publication: PubMed 9482388Triulzi DJ, Griffith BP. Blood usage in lung transplantation. Transfusion. 1998 Jan;38(1):12-5. doi: 10.1046/j.1537-2995.1998.38198141492.x.
- Results publication: PubMed 31147209Cernak V, Oude Lansink-Hartgring A, van den Heuvel ER, Verschuuren EAM, van der Bij W, Scheeren TWL, Engels GE, de Geus AF, Erasmus ME, de Vries AJ. Incidence of Massive Transfusion and Overall Transfusion Requirements During Lung Transplantation Over a 25-Year Period. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2478-2486. doi: 10.1053/j.jvca.2019.03.060. Epub 2019 Mar 30.
- Results publication: PubMed 32718888Huddleston SJ, Jackson S, Kane K, Lemke N, Shaffer AW, Soule M, Hertz M, Shumway S, Qi S, Perry T, Kelly R. Separate Effect of Perioperative Recombinant Human Factor VIIa Administration and Packed Red Blood Cell Transfusions on Midterm Survival in Lung Transplantation Recipients. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3013-3020. doi: 10.1053/j.jvca.2020.05.038. Epub 2020 Jun 3.
- Results publication: PubMed 32622711Seay T, Guinn N, Maisonave Y, Fuller M, Poisson J, Pollak A, Bryner B, Haney J, Klapper J, Hartwig M, Bottiger B. The Association of Increased FFP:RBC Transfusion Ratio to Primary Graft Dysfunction in Bleeding Lung Transplantation Patients. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3024-3032. doi: 10.1053/j.jvca.2020.05.043. Epub 2020 Jun 7.
- Results publication: PubMed 15785389Cimic N, Tulleken JE, Zijlstra JG, van der Bij W, Boonstra PW. Recombinant factor VIIa for refractory hemorrhage after lung transplantation. Transplantation. 2005 Mar 27;79(6):741-2. doi: 10.1097/01.tp.0000147319.66838.71. No abstract available.
- Results publication: PubMed 19695905Felten ML, Fischler M. Intraoperative use of activated recombinant factor VII for refractory bleeding in complicated lung transplantations. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):382-3. doi: 10.1053/j.jvca.2009.06.006. Epub 2009 Aug 19. No abstract available.
- Results publication: PubMed 7598576Detterbeck FC, Egan TM, Mill MR. Lung transplantation after previous thoracic surgical procedures. Ann Thorac Surg. 1995 Jul;60(1):139-43.
- Results publication: PubMed 22944092Ius F, Kuehn C, Tudorache I, Sommer W, Avsar M, Boethig D, Fuehner T, Gottlieb J, Hoeper M, Haverich A, Warnecke G. Lung transplantation on cardiopulmonary support: venoarterial extracorporeal membrane oxygenation outperformed cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1510-6. doi: 10.1016/j.jtcvs.2012.07.095. Epub 2012 Aug 31.
- Results publication: PubMed 28257296Hoechter DJ, Shen YM, Kammerer T, Gunther S, Weig T, Schramm R, Hagl C, Born F, Meiser B, Preissler G, Winter H, Czerner S, Zwissler B, Mansmann UU, von Dossow V. Extracorporeal Circulation During Lung Transplantation Procedures: A Meta-Analysis. ASAIO J. 2017 Sep/Oct;63(5):551-561. doi: 10.1097/MAT.0000000000000549.
- Results publication: PubMed 31402529Adelmann D, Koch S, Menger J, Opfermann P, Jaksch P, Hoetzenecker K, Kurz M, Mouhieddine M, Steinlechner B. Risk factors for early bleeding complications after lung transplantation - a retrospective cohort study. Transpl Int. 2019 Dec;32(12):1313-1321. doi: 10.1111/tri.13491. Epub 2019 Aug 30.
- Results publication: PubMed 7535041Kesten S, de Hoyas A, Chaparro C, Westney G, Winton T, Maurer JR. Aprotinin reduces blood loss in lung transplant recipients. Ann Thorac Surg. 1995 Apr;59(4):877-9. doi: 10.1016/0003-4975(95)00051-l.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Fessler, MD study director
Foch Hospital
Tiffany Pascreau, MD principal investigator
Foch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantra in people with Lung Diseases and Transplant-Related Disorder, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labile blood products measure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05798286, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.