NCT03857217|UnknownDMC
Post-Cardiotomy Extra-Corporeal Life Support Study
PELS
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PELS
Sponsor study identifier
observational
2,000
1 country
1
Study Start
March 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Extracorporeal life support is increasingly used after cardiac surgery. Despite improved technology, outcome still remains poor. This retrospective multicenter cohort study aims to find the (risk) factors associated with the poor prognosis of these patients. Adult patients who received ECLS after cardiac surgery between 2000 and 2018 are eligible for inclusion
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 19, 2019
Actual (reported)February 27, 2019
Actual (reported)March 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In-hospital survival
to assess the rate of survival
within 30 days (expected)
Intra-operative death
To assess the intra-operative rate of death.
within 30 days (expected)
Long-term death
To assess the rate of death at long-term follow-up
within 1-year
Adverse events
during the hospitalization (within 2 months: expected)
Cardiac-related death
during the hospitalization (within 2 months: expected)
Qualify of file
during the hospitalization (within 2 months: expected)
Patients submitted to cardiac surgery
ECMO is implanted in cardiac surgery patients.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients that require ECLS after cardiac screened for inclusion
Maastricht University Medical Centre
Maastricht, Netherlands
Elsharkawy HA, Li L, Esa WA, Sessler DI, Bashour CA. Outcome in patients who require venoarterial extracorporeal membrane oxygenation support after cardiac surgery. J Cardiothorac Vasc Anesth. 2010 Dec;24(6):946-51. doi: 10.1053/j.jvca.2010.03.020.
Rastan AJ, Dege A, Mohr M, Doll N, Falk V, Walther T, Mohr FW. Early and late outcomes of 517 consecutive adult patients treated with extracorporeal membrane oxygenation for refractory postcardiotomy cardiogenic shock. J Thorac Cardiovasc Surg. 2010 Feb;139(2):302-11, 311.e1. doi: 10.1016/j.jtcvs.2009.10.043.
First Submitted
February 19, 2019
First Posted
February 27, 2019
Study Start
March 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 2019
Estimated (date passed)PIONEER Trial:Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI
Contact the study team to confirm eligibility.
Whitman GJ. Extracorporeal membrane oxygenation for the treatment of postcardiotomy shock. J Thorac Cardiovasc Surg. 2017 Jan;153(1):95-101. doi: 10.1016/j.jtcvs.2016.08.024. Epub 2016 Aug 31.
Saxena P, Neal J, Joyce LD, Greason KL, Schaff HV, Guru P, Shi WY, Burkhart H, Li Z, Oliver WC, Pike RB, Haile DT, Schears GJ. Extracorporeal Membrane Oxygenation Support in Postcardiotomy Elderly Patients: The Mayo Clinic Experience. Ann Thorac Surg. 2015 Jun;99(6):2053-60. doi: 10.1016/j.athoracsur.2014.11.075. Epub 2015 Apr 10.
Fukuhara S, Takeda K, Garan AR, Kurlansky P, Hastie J, Naka Y, Takayama H. Contemporary mechanical circulatory support therapy for postcardiotomy shock. Gen Thorac Cardiovasc Surg. 2016 Apr;64(4):183-91. doi: 10.1007/s11748-016-0625-4. Epub 2016 Feb 13.
Sauer CM, Yuh DD, Bonde P. Extracorporeal membrane oxygenation use has increased by 433% in adults in the United States from 2006 to 2011. ASAIO J. 2015 Jan-Feb;61(1):31-6. doi: 10.1097/MAT.0000000000000160.
McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22.
Song JH, Woo WK, Song SH, Kim HH, Kim BJ, Kim HE, Kim do J, Suh JW, Shin YR, Park HK, Lee SH, Joo HC, Lee S, Chang BC, Yoo KJ, Kim YS, Youn YN. Outcome of veno-venous extracorporeal membrane oxygenation use in acute respiratory distress syndrome after cardiac surgery with cardiopulmonary bypass. J Thorac Dis. 2016 Jul;8(7):1804-13. doi: 10.21037/jtd.2016.05.86.
Nakamura H, Yamaguchi H, Amano A, Nakao T. Venovenous extracorporeal membrane oxygenation is effective against post-cardiotomy acute respiratory failure in adults. Gen Thorac Cardiovasc Surg. 2013 Jul;61(7):402-8. doi: 10.1007/s11748-013-0226-4. Epub 2013 Feb 24.
Shekar K, Mullany DV, Thomson B, Ziegenfuss M, Platts DG, Fraser JF. Extracorporeal life support devices and strategies for management of acute cardiorespiratory failure in adult patients: a comprehensive review. Crit Care. 2014 May 9;18(3):219. doi: 10.1186/cc13865.
Bari G, Mariani S, van Bussel BCT, Di Mauro M, Conci L, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, Bunge JJH, Buscher H, Salazar L, Meyns B, Mazzeffi M, Matteucci S, Sponga S, Sorokin V, Russo C, Formica F, Sakiyalak P, Fiore A, Camboni D, Maria Raffa G, Diaz R, Wang IW, Jung JS, Belohlavek J, Pellegrino V, Bianchi G, Pettinari M, Barbone A, Garcia JP, Shekar K, Whitman G, Lorusso R; PELS Investigators. Post-Cardiotomy Extracorporeal Life Support Following Aortic Surgery. ASAIO J. 2026 Oct 1;72(10):e306-e314. doi: 10.1097/MAT.0000000000002619. Epub 2025 Dec 17.
Bunge JJH, Mariani S, Meuwese C, van Bussel BCT, Di Mauro M, Wiedeman D, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, Buscher H, Salazar L, Meyns B, Herr D, Matteucci S, Sponga S, MacLaren G, Russo C, Formica F, Sakiyalak P, Fiore A, Camboni D, Raffa GM, Diaz R, Wang IW, Jung JS, Belohlavek J, Pellegrino V, Bianchi G, Pettinari M, Barbone A, Garcia JP, Shekar K, Whitman GJR, Gommers D, Dos Reis Miranda D, Lorusso R; Post-Cardiotomy Extracorporeal Life Support (PELS-1) Investigators. Characteristics and Outcomes of Prolonged Venoarterial Extracorporeal Membrane Oxygenation After Cardiac Surgery: The Post-Cardiotomy Extracorporeal Life Support (PELS-1) Cohort Study. Crit Care Med. 2024 Oct 1;52(10):e490-e502. doi: 10.1097/CCM.0000000000006349. Epub 2024 Jun 7.
Mariani S, Ravaux JM, van Bussel BCT, De Piero ME, van Kruijk SMJ, Schaefer AK, Wiedemann D, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, Bunge JJH, Buscher H, Salazar L, Meyns B, Mazzeffi MA, Matteucci S, Sponga S, Sorokin V, Russo C, Formica F, Sakiyalak P, Fiore A, Camboni D, Raffa GM, Diaz R, Wang IW, Jung JS, Belohlavek J, Pellegrino V, Bianchi G, Pettinari M, Barbone A, Garcia JP, Shekar K, Whitman GJR, Lorusso R; PELS Investigators. Features and outcomes of female and male patients requiring postcardiotomy extracorporeal life support. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1701-1711.e30. doi: 10.1016/j.jtcvs.2024.04.033. Epub 2024 May 17.
Mariani S, Heuts S, van Bussel BCT, Di Mauro M, Wiedemann D, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, Bunge JJH, Buscher H, Salazar L, Meyns B, Herr D, Matteucci MLS, Sponga S, MacLaren G, Russo C, Formica F, Sakiyalak P, Fiore A, Camboni D, Raffa GM, Diaz R, Wang IW, Jung JS, Belohlavek J, Pellegrino V, Bianchi G, Pettinari M, Barbone A, Garcia JP, Shekar K, Whitman GJR, Lorusso R; PELS-1 Investigators *. Patient and Management Variables Associated With Survival After Postcardiotomy Extracorporeal Membrane Oxygenation in Adults: The PELS-1 Multicenter Cohort Study. J Am Heart Assoc. 2023 Jul 18;12(14):e029609. doi: 10.1161/JAHA.123.029609. Epub 2023 Jul 8.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 27, 2019
Record last verified: 2019-02
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