دورية أكاديمية
Reduced anticoagulation targets in extracorporeal life support (RATE): study protocol for a randomized controlled trial.
| العنوان: | Reduced anticoagulation targets in extracorporeal life support (RATE): study protocol for a randomized controlled trial. |
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| المؤلفون: | van Minnen, Olivier, Oude Lansink-Hartgring, Annemieke, van den Boogaard, Bas, van den Brule, Judith, Bulpa, Pierre, Bunge, Jeroen J H, Delnoij, Thijs S R, Elzo Kraemer, Carlos V, Kuijpers, Marijn, Lambermont, Bernard, Maas, Jacinta J, de Metz, Jesse, Michaux, Isabelle, van de Pol, Ineke, van de Poll, Marcel, Raasveld, S Jorinde, Raes, Matthias, Dos Reis Miranda, Dinis, Scholten, Erik, Simonet, Olivier, Taccone, Fabio S, Vallot, Frederic, Vlaar, Alexander P J, van den Bergh, Walter M |
| المصدر: | Trials, 23 (1), 405 (2022-05-16) |
| بيانات النشر: | BioMed Central Ltd, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Anticoagulation, Complications, ECMO, Anticoagulants, Heparin, Low-Molecular-Weight, Heparin, Adult, Anticoagulants/adverse effects, Heparin/adverse effects, Heparin, Low-Molecular-Weight/adverse effects, Humans, Randomized Controlled Trials as Topic, Extracorporeal Membrane Oxygenation/adverse effects, Extracorporeal Membrane Oxygenation/methods, Ischemic Stroke, Extracorporeal Membrane Oxygenation, Medicine (miscellaneous), Pharmacology (medical), Human health sciences, Anesthesia & intensive care, Sciences de la santé humaine, Anesthésie & soins intensifs |
| الوصف: | [en] BACKGROUND: Although life-saving in selected patients, ECMO treatment still has high mortality which for a large part is due to treatment-related complications. A feared complication is ischemic stroke for which heparin is routinely administered for which the dosage is usually guided by activated partial thromboplastin time (aPTT). However, there is no relation between aPTT and the rare occurrence of ischemic stroke (1.2%), but there is a relation with the much more frequent occurrence of bleeding complications (55%) and blood transfusion. Both are strongly related to outcome.METHODS: We will conduct a three-arm non-inferiority randomized controlled trial, in adult patients treated with ECMO. Participants will be randomized between heparin administration with a target of 2-2.5 times baseline aPTT, 1.5-2 times baseline aPTT, or low molecular weight heparin guided by weight and renal function. Apart from anticoagulation targets, treatment will be according to standard care. The primary outcome parameter is a combined endpoint consisting of major bleeding including hemorrhagic stroke, severe thromboembolic complications including ischemic stroke, and mortality at 6 months.DISCUSSION: We hypothesize that with lower anticoagulation targets or anticoagulation with LMWH during ECMO therapy, patients will have fewer hemorrhagic complications without an increase in thromboembolic complication or a negative effect on their outcome. If our hypothesis is confirmed, this study could lead to a change in anticoagulation protocols and a better outcome for patients treated with ECMO.TRIAL REGISTRATION: ClinicalTrials.gov NCT04536272 . Registered on 2 September 2020. Netherlands Trial Register NL7969. |
| نوع الوثيقة: | journal article http://purl.org/coar/resource_type/c_6501Test article peer reviewed |
| اللغة: | English |
| العلاقة: | https://link.springer.com/content/pdf/10.1186/s13063-022-06367-w.pdfTest; 10.1186/s13063-022-06367-w; urn:issn:1745-6215 |
| DOI: | 10.1186/s13063-022-06367-w |
| الوصول الحر: | https://orbi.uliege.be/handle/2268/300777Test |
| حقوق: | open access http://purl.org/coar/access_right/c_abf2Test info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsorb.300777 |
| قاعدة البيانات: | ORBi |
| DOI: | 10.1186/s13063-022-06367-w |
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