Background The Netherlands Armed Forces have been successfully using deep-frozen (- 80 degrees C) thrombocyte concentrate (DTC) for the treatment of (massive) bleeding trauma patients in austere... Show moreBackground The Netherlands Armed Forces have been successfully using deep-frozen (- 80 degrees C) thrombocyte concentrate (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for the effectiveness and safety of DTCs is currently lacking. Therefore, the MAssive transfusion of Frozen bloOD (MAFOD) trial is designed to compare the haemostatic effect of DTCs versus room temperature-stored platelets (RSP) in the treatment of surgical bleeding. Methods The MAFOD trial is a single-blinded, randomized controlled non-inferiority trial and will be conducted in three level 1 trauma centres in The Netherlands. Patients 12 years or older, alive at hospital presentation, requiring a massive transfusion including platelets and with signed (deferred) consent will be included. The primary outcome is the percentage of patients that have achieved haemostasis within 6 h and show signs of life. Haemostasis is defined as the time in minutes from arrival to the time of the last blood component transfusion (plasma/platelets or red blood cells), followed by a 2-h transfusion-free period. This is the first randomized controlled study investigating DTCs in trauma and vascular surgical bleeding. Discussion The hypothesis is that the percentage of patients that will achieve haemostasis in the DTC group is at least equal to the RSP group (85%). With a power of 80%, a significance level of 5% and a non-inferiority limit of 15%, a total of 71 patients in each arm are required, thus resulting in a total of 158 patients, including a 10% refusal rate. The data collected during the study could help improve the use of platelets during resuscitation management. If proven non-inferior in civilian settings, frozen platelets may be used in the future to optimize logistics and improve platelet availability in rural or remote areas for the treatment of (massive) bleeding trauma patients in civilian settings. Show less
Klok, F.A.; Ageno, W.; Ay, C.; Back, M.; Barco, S.; Bertoletti, L.; ... ; Pruszczyk, P. 2022
This position paper provides a comprehensive guide for optimal follow-up of patients with acute pulmonary embolism (PE), covering multiple relevant aspects of patient counselling. It serves as a... Show moreThis position paper provides a comprehensive guide for optimal follow-up of patients with acute pulmonary embolism (PE), covering multiple relevant aspects of patient counselling. It serves as a practical guide to treating patients with acute PE complementary to the formal 2019 European Society of Cardiology guidelines developed with the European Respiratory Society. We propose a holistic approach considering the whole spectrum of serious adverse events that patients with acute PE may encounter on the short and long run. We underline the relevance of assessment of modifiable risk factors for bleeding, of acquired thrombophilia and limited cancer screening (unprovoked PE) as well as a dedicated surveillance for the potential development of chronic thromboembolic pulmonary hypertension as part of routine practice; routine testing for genetic thrombophilia should be avoided. We advocate the use of outcome measures for functional outcome and quality of life to quantify the impact of the PE diagnosis and identify patients with the post-PE syndrome early. Counselling patients on maintaining a healthy lifestyle mitigates the risk of the post-PE syndrome and improves cardiovascular prognosis. Therefore, we consider it important to discuss when and how to resume sporting activities soon after diagnosing PE. Additional patient-relevant topics that require Focused counselling are travel and birth control. Show less
Aim of this thesis was to evaluate contemporary care and prognosis for patients with acute coronary syndrome and identify pitfalls in its treatment. Complications after coronary stent implantation... Show moreAim of this thesis was to evaluate contemporary care and prognosis for patients with acute coronary syndrome and identify pitfalls in its treatment. Complications after coronary stent implantation were explored and demonstrated that in sirolimus-eluting stents, the benefit of reduced repeat revascularization during one year after primary PCI was not sustained during long-term follow-up. Additionally, an increased risk of very late stent thrombosis was suggested. Late stent malapposition, more commonly observed after this stent type and suspected to be involved in the multifactorial etiology of stent thrombosis, is shown to persist in the greater portion of STEMI patients during long-term follow-up, depending on the degree of vessel wall remodelling and change in plaque burden. Women were identified as a sub-population with poorer prognosis early after STEMI. Identification of high-risk patients, and estimation of infarct size and prognosis, which a single measurement of troponin already may indicate, facilitates individualized treatment and likely results in better outcomes. Although numerous novel treatment modalities emerged in recent years, certain pitfalls become increasingly important. Major bleeding is one of them, responsible for an excess mortality amongst STEMI patients after primary PCI, and should be incorporated in risk stratification models for the choice of treatment strategy. Show less
