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Epidural and Intrathecal Analgesia
Published in Pamela E. Macintyre, Stephan A. Schug, Acute Pain Management, 2021
Pamela E. Macintyre, Stephan A. Schug
In addition to their guidelines (Horlocker et al, 2018), the American Society of Regional Anesthesia and Pain Medicine (ASRA) produces a useful app (ASRA Coags) incorporating these guidelines, where a search can be made for each antithrombotic or thrombolytic drug and then different management suggestions for patients having a neuraxial block or deep plexus, a peripheral or superficial block will be displayed.
Selected Statistical Topics of Regulatory Importance
Published in Demissie Alemayehu, Birol Emir, Michael Gaffney, Interface between Regulation and Statistics in Drug Development, 2020
Demissie Alemayehu, Birol Emir, Michael Gaffney
This example concerns the use of a non-inferiority study for approval of a new thrombolytic agent for the treatment of acute myocardial infarction. Streptokinase was the active comparator and its effect was established by a meta-analysis of placebo-controlled trials. Streptokinase yielded a 2.6% benefit in mortality compared to placebo with a one-sided 95% lower bound of 2.1%. The one-sided 95% lower confidence bound of 2.1% was taken as the effect of streptokinase for the purposes of the NI study rather than the most likely estimate of 2.6% because the NI study is dependent on something that is not measured in the NI study, namely, the effect of streptokinase over placebo. Thus, the conservative estimate of 2.1% was selected to increase the confidence that this effect would be present in the NI study. While 2.1% could serve as an acceptable NIM to show efficacy for the new agent, the clinical /regulatory decision was made that the NI study should rule out a loss of more than half of the benefit of streptokinase to be an acceptable alternative. The NI study would therefore have to rule out an NIM of a 1.05% increase in mortality in patients treated with the new thrombolytic drug compared to those treated with streptokinase. Figure 2.2 illustrates these values.
A critical look at orthodox medical approaches
Published in Geraldine Lee-Treweek, Tom Heller, Hilary MacQueen, Julie Stone, Sue Spurr, Complementary and Alternative Medicine: Structures and Safeguards, 2020
Tom Heller, Dick Heller, Gavin Yamey
The best treatment for a person who has a stroke is to use a thrombolytic drug to unblock the blocked artery. Only seven people have to be treated with such an agent to prevent one of those seven dying or becoming dependent on someone else. Using aspirin in this situation, 33 people have to be treated to prevent a bad outcome. It seems obvious that the decision should be to use the ‘unblocker’. However, closer inspection of the data reveals that only 4 per cent of people who have a stroke are eligible for the treatment because (a) it is only effective if given very soon after the stroke and (b) it can only be used after a head scan to ensure it is not used for a type of stroke where it would cause more harm than good. Aspirin can be given to 70 per cent of people after a stroke. It is less beneficial to the individual but it can be used in more people and it costs much less (Ebrahim, 1999). The balance between benefits to the individual and the population is complex, is the basis of much health policy decision-making, and has led to a set of methods being developed to extend EBM by giving it a population focus (Heller and Dobson, 2000).
Massive postpartum pulmonary embolism successfully treated with v-a-v ECMO: a case report
Published in Journal of Obstetrics and Gynaecology, 2021
Greta Balciuniene, Lukas Balciunas, Lina Jakubauskiene, Diana Ramasauskaite, Mindaugas Serpytis, Lina Gumbiene, Jurate Dementaviciene
According to the latest systematic review (Martillotti et al. 2017) on this topic, the most commonly used method for the management of pulmonary embolism is thrombolysis. It was opted for 65.4% of patients, including cases with several modalities of treatment. The maternal survival of patients who received postpartum thrombolysis reached 84.5%; however, 58.3% of patients suffered from a major haemorrhage. This number was greater compared with a risk of major bleeding during pregnancy. Most of the bleeding complications were due to vaginal haemorrhages or intraabdominal bleeding after c-section. Moreover, a fatal intracranial haemorrhage is also mentioned 7 days after the use of thrombolytic drug (Yang and Lin 2014). Our case indicates that ECMO with anticoagulative therapy could be an alternative to standard pulmonary embolism treatment, especially for patients who has high risk for bleeding complications.
EkoSonic® endovascular system and other catheter-directed treatment reperfusion strategies for acute pulmonary embolism: overview of efficacy and safety outcomes
Published in Expert Review of Medical Devices, 2020
Lukas Hobohm, Karsten Keller, Thomas Münzel, Tommaso Gori, Stavros V. Konstantinides
Patients with acute PE have partial or complete occlusion of several pulmonary branches, which create shunting of blood stream from the obstructed toward to unobstructed parts of the lung. Thus, if thrombolysis is administered systemically (intravenously), the thrombolytic agent would be expected to reach only a fraction of the surface of the clot. For this reason, significantly lower doses of the thrombolytic agent might be necessary if delivered via a catheter traversing (or at least inserted very close to) the thrombosed vascular segment; at the same time, the dose reduction might minimize systemic bleeding effects of thrombolysis [19,20]. Based on this principle, catheter-directed lysis focuses on delivery of a low dose (25% of the systemic doses, or less) of the thrombolytic drug directly into the pulmonary arteries, alone or in combination with ultrasound assistance to accelerate the penetration and dissolution of the clot; alternative methods involve mechanical clot fragmentation or direct clot aspiration [21].
Thrombus heterogeneity in ischemic stroke
Published in Platelets, 2021
Senna Staessens, Simon F. De Meyer
At present, rt-PA is the only FDA-approved thrombolytic drug available. However, rt-PA can only be administered within a short time window of 4.5 hours after stroke onset due to the increased risk of hemorrhagic complications that outweighs the benefit of rt-PA administration beyond this therapeutic time frame. As a consequence, rt-PA is available to less than 15% of patients in most European countries [47]. Importantly, in more than half of patients who receive rt-PA, no successful recanalization can be achieved [48]. The reasons of this so-called rt-PA resistance are not well understood but thrombus composition is most likely part of the answer. Given the current limitations regarding rt-PA therapy, it is clear that additional pharmacological strategies are required.