Quantra® System With the QPlus® Cartridge in Double-lung Transplantation
NCT ID: NCT05798286
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
128 participants
INTERVENTIONAL
2023-05-15
2025-10-03
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
Quantra
The study plans to collect 2 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts.
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.
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.
Interventions
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Quantra
The study plans to collect 2 additional 3 mL citrate tubes of venous blood in addition to the platelet and blood counts.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Julien Fessler, MD
Role: STUDY_DIRECTOR
Foch Hospital
Tiffany Pascreau, MD
Role: PRINCIPAL_INVESTIGATOR
Foch Hospital
Locations
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Foch Hospital
Suresnes, , France
Countries
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References
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Triulzi DJ, Griffith BP. Blood usage in lung transplantation. Transfusion. 1998 Jan;38(1):12-5. doi: 10.1046/j.1537-2995.1998.38198141492.x.
Cernak 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.
Huddleston 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.
Seay 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.
Cimic 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.
Felten 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.
Detterbeck FC, Egan TM, Mill MR. Lung transplantation after previous thoracic surgical procedures. Ann Thorac Surg. 1995 Jul;60(1):139-43.
Ius 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.
Hoechter 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.
Adelmann 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.
Kesten 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.
Balsara 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.
Bittner 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.
Bittner 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.
Marasco SF, Pilcher D, Oto T, Chang W, Griffiths A, Pellegrino V, Chan J, Bailey M. Aprotinin in lung transplantation is associated with an increased incidence of primary graft dysfunction. Eur J Cardiothorac Surg. 2010 Feb;37(2):420-5. doi: 10.1016/j.ejcts.2009.08.007. Epub 2009 Sep 19.
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.
Other Identifiers
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2020_0084
Identifier Type: -
Identifier Source: org_study_id
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