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

NCT05798286 | Active Not Recruiting

• 1 other identifier: 2020_0084
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; Transplant-Related Disorder

Keywords

Resonance sonorheometry; Viscoelastic testing; Quantra system; Lung transplantation

Outcome Measures

Primary Outcomes (1)

• Labile blood products measure

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

  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

  24 hours

• blood loss during surgery

  24 hours

• The occurrence of acute primary graft dysfunction at day 3.

  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

  6 months

• Hospital mortality, at 30 days, 90 days, and 12 months

  12 months

Study Arms (2)

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.

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.

Other: Control

Interventions

Quantra OTHER

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

QUANTRA group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Foch Hospital

Suresnes, 92150, France

Location

Related Publications (16)

• 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.

  PMID: 9482388 BACKGROUND

• 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.

  PMID: 31147209 BACKGROUND

• 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.

  PMID: 32718888 BACKGROUND

• 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.

  PMID: 32622711 BACKGROUND

• 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.

  PMID: 15785389 BACKGROUND

• 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.

  PMID: 19695905 BACKGROUND

• Detterbeck FC, Egan TM, Mill MR. Lung transplantation after previous thoracic surgical procedures. Ann Thorac Surg. 1995 Jul;60(1):139-43.

  PMID: 7598576 BACKGROUND

• 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.

  PMID: 22944092 BACKGROUND

• 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.

  PMID: 28257296 BACKGROUND

• 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.

  PMID: 31402529 BACKGROUND

• 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.

  PMID: 7535041 BACKGROUND

• 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.

  PMID: 18669527 BACKGROUND

• 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.

  PMID: 16386921 BACKGROUND

• 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.

  PMID: 17362765 BACKGROUND

• 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.

  PMID: 19767212 BACKGROUND

• 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.

  PMID: 20731686 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Julien Fessler, MD

  Foch Hospital

  STUDY DIRECTOR

• Tiffany Pascreau, MD

  Foch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel group

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 4, 2023
• Study Start: May 15, 2023
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)