Immunological Responses in Bovine vs Mechanical Composite Grafts
NCT ID: NCT04010396
Last Updated: 2021-11-23
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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COMPLETED
30 participants
OBSERVATIONAL
2019-09-01
2020-04-30
Brief Summary
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In the second prospective part the investigators will select survivors from the first part with and without inflammation signs. If they consent to participate in the study the investigators will do a blood sampling in order to perform further immunological analysis. Additionally, the investigators will examine their quality of life by QoL SF-12 questionnaire.
Detailed Description
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Analyzing CT or MRI report at following time intervals: 3 - 6 months postoperatively, 1, 2 and 3 years postoperatively (regular check-up appointments in clinics).
Additionally, extraction of following data-set (based on availability): temperature, lab values (C-reactive protein, white blood count, Eosinophil count), pathology report and CT- / MRI- imaging in cases of re-operation.
Firstly, identify if there is a graft inflammation (positive / negative group within the bovine group).
Secondly, compare to mechanical group.
Part 2 Choose 10 + 10 patients of the bovine group (with / without immune response) and 10 of the mechanical group in order to conduct further immunological testing and comparison. The immunological testing will include measurement of immunoglobulin E and immunoglobulin G antibodies against bovine protein, as well as in vitro T cell reactivity in Interleukin 4 and interferon-gamma Elispot. These parameters will characterize whether the patient mounted an adaptive immune response against the bovine protein. In addition, the investigators will measure total immunoglobulin G4 and Interleukin-6 levels in the serum of all patients, as additional inflammation markers.
Contact patients to come into clinics for a visit, explain study. Blood sampling (1 serum and 1 EDTA) after patients consent.
Material will be sampled and sent in anonymized form via express courier to the Translational Immunology Lab at the University Hospital Basel. Samples will be processed within 24h to isolate peripheral blood mononuclear cells (PBMC) and serum. PBMC and Serum will be cryopreserved at -180°C and -80°C respectively. Samples will be analyzed in batches each including 3-5 subjects per group.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Recipients of Bovine Graft
Recruitment and informed consent procedure for blood sampling to conduct immunological testing. In addition a questionnaire on QOL (SF-12) will be used to evaluate the most actual quality of life of these patients.
Blood sampling
Blood sampling: 1 EDTA and 1 Serum vial
Recipients of Mechanical Graft
Recruitment and informed consent procedure for blood sampling to conduct immunological testing. In addition a questionnaire on QOL (SF-12) will be used to evaluate the most actual quality of life of these patients.
Blood sampling
Blood sampling: 1 EDTA and 1 Serum vial
Interventions
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Blood sampling
Blood sampling: 1 EDTA and 1 Serum vial
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability or any contraindications to undergo the planned investigated intervention, clinically significant concomitant diseases precluding ambulatory control in the day clinic in Bern.
18 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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ThierryThierry Prof. Dr. med. Carrel
Role: STUDY_CHAIR
Department Chair
Locations
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University Hospital Bern, Inselspital
Bern, , Switzerland
Countries
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References
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Carrel TP, Schoenhoff FS, Schmidli J, Stalder M, Eckstein FS, Englberger L. Deleterious outcome of No-React-treated stentless valved conduits after aortic root replacement: why were warnings ignored? J Thorac Cardiovasc Surg. 2008 Jul;136(1):52-7. doi: 10.1016/j.jtcvs.2007.09.047. Epub 2008 May 27.
Carrel T, Reineke D, Englberger L. Another report on unfavourable long-term outcome following implantation of the Shelhigh No-React valved tube graft. Eur J Cardiothorac Surg. 2016 Dec;50(6):1179-1180. doi: 10.1093/ejcts/ezw205. Epub 2016 Jun 14. No abstract available.
Reineke DC, Kaya A, Heinisch PP, Oezdemir B, Winkler B, Huber C, Heijmen RH, Morshuis W, Carrel TP, Englberger L. Long-term follow-up after implantation of the Shelhigh(R) No-React(R) complete biological aortic valved conduit. Eur J Cardiothorac Surg. 2016 Jul;50(1):98-104. doi: 10.1093/ejcts/ezv452. Epub 2015 Dec 30.
Gisler F, Huber C, Wenaweser P, Carrel T. Severe calcification of a Shelhigh stentless valved conduit. Eur J Cardiothorac Surg. 2014 Aug;46(2):334. doi: 10.1093/ejcts/ezt569. Epub 2013 Dec 11. No abstract available.
Schoenhoff FS, Loup O, Gahl B, Banz Y, Pavlovic M, Pfammatter JP, Carrel TP, Kadner A. The Contegra bovine jugular vein graft versus the Shelhigh pulmonic porcine graft for reconstruction of the right ventricular outflow tract: a comparative study. J Thorac Cardiovasc Surg. 2011 Mar;141(3):654-61. doi: 10.1016/j.jtcvs.2010.06.068. Epub 2011 Jan 20.
Carrel TP. Another disastrous outcome following aortic root replacement with the Shelhigh No-react aortic valved tube. Thorac Cardiovasc Surg. 2008 Aug;56(5):314-5. doi: 10.1055/s-2008-1038472. No abstract available.
Englberger L, Noti J, Immer FF, Stalder M, Eckstein FS, Carrel TP. The Shelhigh No-React bovine internal mammary artery: a questionable alternative conduit in coronary bypass surgery? Eur J Cardiothorac Surg. 2008 Feb;33(2):222-4. doi: 10.1016/j.ejcts.2007.11.006. Epub 2007 Dec 20.
Sahin A, Muggler O, Sromicki J, Caliskan E, Reser D, Emmert MY, Alkadhi H, Maisano F, Falk V, Holubec T. Long-term follow-up after aortic root replacement with the Shelhigh(R) biological valved conduit: a word of caution! Eur J Cardiothorac Surg. 2016 Dec;50(6):1172-1178. doi: 10.1093/ejcts/ezw167. Epub 2016 May 26.
Kaya A, Heijmen RH, Kelder JC, Schepens MA, Morshuis WJ. Stentless biological valved conduit for aortic root replacement: initial experience with the Shelhigh BioConduit model NR-2000C. J Thorac Cardiovasc Surg. 2011 May;141(5):1157-62. doi: 10.1016/j.jtcvs.2010.07.009. Epub 2010 Sep 15.
Other Identifiers
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24.06.2019 V 1.0
Identifier Type: -
Identifier Source: org_study_id