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Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?

PURPOSE: Percutaneous hepatic perfusion (PHP) is a palliative intraarterial therapy for unresectable hepatic malignancies. During PHP, high-dose melphalan is infused via the hepatic artery to saturate tumor in the liver with the chemotherapeutic substance. The venous hepatic blood is filtered by an...

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Autores principales: Facchetti, Nadia, Hinrichs, Jan B., Becker, Lena S., Schneider, Martin A., Brüning, Roland, Rademacher, Jan, Lenz, Jochen, Kudrass, Kirsten, Vogel, Arndt, Wacker, Frank K., Dewald, Cornelia L. A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10349410/
https://www.ncbi.nlm.nih.gov/pubmed/37452405
http://dx.doi.org/10.1186/s40644-023-00590-7
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author Facchetti, Nadia
Hinrichs, Jan B.
Becker, Lena S.
Schneider, Martin A.
Brüning, Roland
Rademacher, Jan
Lenz, Jochen
Kudrass, Kirsten
Vogel, Arndt
Wacker, Frank K.
Dewald, Cornelia L. A.
author_facet Facchetti, Nadia
Hinrichs, Jan B.
Becker, Lena S.
Schneider, Martin A.
Brüning, Roland
Rademacher, Jan
Lenz, Jochen
Kudrass, Kirsten
Vogel, Arndt
Wacker, Frank K.
Dewald, Cornelia L. A.
author_sort Facchetti, Nadia
collection PubMed
description PURPOSE: Percutaneous hepatic perfusion (PHP) is a palliative intraarterial therapy for unresectable hepatic malignancies. During PHP, high-dose melphalan is infused via the hepatic artery to saturate tumor in the liver with the chemotherapeutic substance. The venous hepatic blood is filtered by an extracorporeal melphalan specific filtration system. Blood clotting in the extracorporeal filter system is prevented by administering unfractionated heparin (UFH) in high doses, which might be reversed with protamine sulfate after the procedure. Aim of this retrospective two-center-study was to analyze the potential effect of UFH reversal with protamine sulfate on complication rates following PHP. MATERIALS AND METHODS: All patients receiving PHP treatment between 10/2014 and 04/2021 were classified according to their intraprocedural coagulation management: 92 patients/192 PHP received full UFH reversal with protamine (group(PROTAMINE)); 13 patients/21 PHP in group(REDUCED_PROTAMINE) received a reduced amount of protamine, and 28 patients/43 PHP did not receive UFH reversal with protamine (group(NO_PROTAMINE)). Periinterventional clinical reports, findings and laboratory values were retrospectively evaluated. Complications and adverse events were classified according to Common Terminology Criteria for Adverse Events (CTCAEv5.0). RESULTS: Thromboembolic events were recorded after 10 PHP procedures (5%) in group(PROTAMINE), six of which (3%) were major events (CTCAE grade 3-5). No (0%) thromboembolic events were recorded in group(REDUCED_PROTAMINE) and group(NO_PROTAMINE). Hemorrhagic events were registered after 24 PHP (13%) in group(PROTAMINE,) two of which (1%) were major (CTCAE grade 3-4). In group(REDUCED_PROTAMINE), only minor bleeding events were recorded, and one major hemorrhagic event was documented in group(NO_PROTAMINE) (2%). There was a significant difference between the percentage of post-interventional thrombopenia in group(PROTAMINE) (39%) and group(REDUCED_PROTAMINE) (14%) versus group(NO_PROTAMINE) (23%) (p=.00024). In group(PROTAMINE) one patient suffered from a severe anaphylactic shock after the administration of protamine. CONCLUSION: Our retrospective study implies that there might be a link between the practice of protamine sulfate administration to reverse the full hemodilutive effect of UFH after PHP and the post-interventional risk of thromboembolic events as well as clinically significant thrombopenia. Our data suggest that the standard use of protamine sulfate after PHP in low-risk patients without clinical signs of active bleeding should be critically re-evaluated.
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spelling pubmed-103494102023-07-16 Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more? Facchetti, Nadia Hinrichs, Jan B. Becker, Lena S. Schneider, Martin A. Brüning, Roland Rademacher, Jan Lenz, Jochen Kudrass, Kirsten Vogel, Arndt Wacker, Frank K. Dewald, Cornelia L. A. Cancer Imaging Research Article PURPOSE: Percutaneous hepatic perfusion (PHP) is a palliative intraarterial therapy for unresectable hepatic malignancies. During PHP, high-dose melphalan is infused via the hepatic artery to saturate tumor in the liver with the chemotherapeutic substance. The venous hepatic blood is filtered by an extracorporeal melphalan specific filtration system. Blood clotting in the extracorporeal filter system is prevented by administering unfractionated heparin (UFH) in high doses, which might be reversed with protamine sulfate after the procedure. Aim of this retrospective two-center-study was to analyze the potential effect of UFH reversal with protamine sulfate on complication rates following PHP. MATERIALS AND METHODS: All patients receiving PHP treatment between 10/2014 and 04/2021 were classified according to their intraprocedural coagulation management: 92 patients/192 PHP received full UFH reversal with protamine (group(PROTAMINE)); 13 patients/21 PHP in group(REDUCED_PROTAMINE) received a reduced amount of protamine, and 28 patients/43 PHP did not receive UFH reversal with protamine (group(NO_PROTAMINE)). Periinterventional clinical reports, findings and laboratory values were retrospectively evaluated. Complications and adverse events were classified according to Common Terminology Criteria for Adverse Events (CTCAEv5.0). RESULTS: Thromboembolic events were recorded after 10 PHP procedures (5%) in group(PROTAMINE), six of which (3%) were major events (CTCAE grade 3-5). No (0%) thromboembolic events were recorded in group(REDUCED_PROTAMINE) and group(NO_PROTAMINE). Hemorrhagic events were registered after 24 PHP (13%) in group(PROTAMINE,) two of which (1%) were major (CTCAE grade 3-4). In group(REDUCED_PROTAMINE), only minor bleeding events were recorded, and one major hemorrhagic event was documented in group(NO_PROTAMINE) (2%). There was a significant difference between the percentage of post-interventional thrombopenia in group(PROTAMINE) (39%) and group(REDUCED_PROTAMINE) (14%) versus group(NO_PROTAMINE) (23%) (p=.00024). In group(PROTAMINE) one patient suffered from a severe anaphylactic shock after the administration of protamine. CONCLUSION: Our retrospective study implies that there might be a link between the practice of protamine sulfate administration to reverse the full hemodilutive effect of UFH after PHP and the post-interventional risk of thromboembolic events as well as clinically significant thrombopenia. Our data suggest that the standard use of protamine sulfate after PHP in low-risk patients without clinical signs of active bleeding should be critically re-evaluated. BioMed Central 2023-07-14 /pmc/articles/PMC10349410/ /pubmed/37452405 http://dx.doi.org/10.1186/s40644-023-00590-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Facchetti, Nadia
Hinrichs, Jan B.
Becker, Lena S.
Schneider, Martin A.
Brüning, Roland
Rademacher, Jan
Lenz, Jochen
Kudrass, Kirsten
Vogel, Arndt
Wacker, Frank K.
Dewald, Cornelia L. A.
Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?
title Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?
title_full Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?
title_fullStr Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?
title_full_unstemmed Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?
title_short Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?
title_sort heparin reversal with protamine sulfate after percutaneous hepatic perfusion (php): is less more?
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10349410/
https://www.ncbi.nlm.nih.gov/pubmed/37452405
http://dx.doi.org/10.1186/s40644-023-00590-7
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