Powers et al 2018 Guidelines for Management of Acute Ischemic Stroke e47 N ew high-quality evidence has produced major changes in the evidence-based treatment of patients with acute ischemic stroke (AIS) since the publication of the most recent “Guidelines for the Early Management of Patients The guideline panel determined that there is moderate certainty in the evidence that the desirable consequences of mechanical prophylaxis outweigh the undesirable consequences in acutely or critically ill medical patients. Specifically, we invited the APEX trial investigators to provide information about outcomes including all-cause mortality, PE, symptomatic DVT, and major bleeding at the end of short-term treatment with enoxaparin or oral DOAC. The McMaster University GRADE Centre supported the guideline-development process, including updating or performing systematic evidence reviews. The EtD framework is shown at https://dbep.gradepro.org/profile/B7E7908E-FFD0-19C4-862E-16561BEC51FE. None of the 5 trials reported serious adverse effects of wearing the stockings, but in 1 trial, 4 patients developed varicose vein thrombosis, possibly as a result of the stockings.165  The panel was concerned about potential allergy to the stocking material, but this adverse effect was not reported in the trials. 0000004057 00000 n Provoked venous thromboembolism in non-cancer patients: are they the same? Critically ill patients were defined as suffering from an immediately life-threatening condition admitted to an intensive or critical care unit. We did not address whether twice or thrice daily unfractionated heparin should be used when unfractionated heparin is chosen, because we did not develop a guideline question for this, there are little data, and there are no recent data. LMWH showed reductions in PE, symptomatic DVT, major bleeding, and HIT compared with UFH, but the estimates were imprecise, with small ARRs (see evidence profile in the online EtD framework). Interpretation of strong and conditional recommendations. PDF | Venous thromboembolism ... 2019 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer. Other EtD criteria were generally in favor of using in-hospital prophylaxis only, because the undesirable consequences were greater than the desirable consequences in acutely ill medical patients, leading to a recommendation for shorter prophylaxis. We identified 1 systematic review evaluating the risk of a symptomatic DVT event within 4 weeks of flights longer than 4 hours. 0000027396 00000 n 0000004962 00000 n The panel assumed that avoidance of death, PE, and DVT was critical or important to patients for decision making. The panel also suggested that pneumatic compression devices might reduce mobility and cause falls in patients who ambulate, although the panel did not review specific evidence for these outcomes, and some evidence suggests no increased risk of falls with pneumatic compression devices.139. The panel assumed that avoidance of PE, DVT, and bleeding events was critical or important to patients for decision making but that using extended prophylaxis could cause inequity because of concerns about cost and the ability to self-inject. The ASH panel recommended LMWH or fondaparinux over UFH. When existing reviews were used, judgments of the original authors about risk for bias were either randomly checked for accuracy and accepted or conducted de novo if they were not available or not reproducible. We used 1 systematic review summarizing evidence for patients with trauma123  and 1 systematic review in patients with stroke.132  Our update of these systematic reviews did not identify any additional eligible studies. For LMWH and aspirin, people with substantially increased risk for VTE (eg, recent surgery, history of VTE, hormone replacement therapy, pregnant or postpartum women, active malignancy, or ≥2 VTE risk factors) may experience more health benefits than harms. EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study, Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial, Rivaroxaban for thromboprophylaxis after hospitalization for medical illness, Can home prophylaxis for venous thromboembolism reduce mortality rates in patients with chronic obstructive pulmonary disease? 0000026415 00000 n NCCN Guidelines are widely recognized and used as the standard for clinical policy in oncology by clinicans and payors. Question: Should mechanical combined with pharmacological vs pharmacological VTE prophylaxis alone be used in acutely or critically ill medical patients? Performance measures should assess whether decision making is appropriate. Question: Should any DOAC extended beyond hospital discharge vs non-DOAC VTE prophylaxis administered in hospital only be used in acutely ill medical patients? Conditional recommendations included not to use VTE prophylaxis routinely in long-term care patients or outpatients with minor VTE risk factors. Two RCTs reported an increase in gastrointestinal bleeding (RR, 2.61; 95% CI, 0.36-18.86; ARR, 50 more per 1000; 95% CI, from 20 fewer to 558 more per 1000), and 3 reported little impact on thrombocytopenia (RR, 0.95; 95% CI, 0.47-1.92; ARR, 0 per 1000; 95% CI, from 1 fewer to 2 more per 1000), with 1 of the studies specifically reporting no HIT in either group. The final guidelines, including recommendations, were reviewed and approved by all members of the panel. Given that this recommendation was based on indirect data and extrapolation from acutely ill medical patients, further research in critically ill medical patients is required. For distal DVT, this extrapolated to an ARI of 7 more per 1000 (95% CI, 3 fewer to 40 more per 1000) using a baseline risk of 0.7%. The ultimate judgment regarding any specific clinical procedure or treatment must be made by the physician in light of the circumstances presented by the patient. Overall, the panel judged that, for all interventions, the undesirable consequences were greater than the desirable consequences and made recommendations against their use, with the exception of patients with VTE risk factors. 0000009067 00000 n Question: Should any DOAC extended beyond hospital discharge vs standard duration non-DOAC VTE prophylaxis administered in hospital only be used in acutely ill medical patients? 0000004216 00000 n These associations were no longer evident by 12 weeks after travel. Project oversight was provided initially by a coordination panel, which reported to the ASH Committee on Quality, and then by the coordination panel chair (Dr. Adam Cuker) and vice-chair (H.J.S.). Evidence for outpatients with cancer is addressed in a separate ASH guideline. The panel considered the certainty in these estimated effects as very low owing to very serious imprecision and indirectness (see evidence profile and online EtD framework). 0000024175 00000 n [Guideline] Witt DM, Nieuwlaat R, Clark NP, et al. Of the 3 included studies, 2 of them115,117  assessed the effect of LMWH, whereas 1 study117  assessed the effect of UFH. Question: Should mechanical combined with pharmacological VTE prophylaxis vs pharmacological VTE prophylaxis alone be used in acutely or critically ill medical patients? The American Society of Hematology (ASH), the world’s largest professional society concerned with the causes and treatment of blood disorders, has long recognized the need for a comprehensive set of guidelines on the treatment of VTE to help the medical community better manage this serious condition. The EtD framework is shown at https://dbep.gradepro.org/profile/783DCF1B-50FC-72D0-A1E1-3C31011E9471. The tolerability of graduated compression stockings was described as very good, with no reported side effects in 4 RCTs. Overall, the certainty in these estimated effects was rated as very low owing to risk of bias and imprecision of the estimates (see evidence profile in the online EtD framework). Remark: If a patient’s status changes to acute, other recommendations would apply. 0000028448 00000 n In the 3 trials, extended use of a DOAC led to an increased risk for major bleeding (RR, 1.99; 95% CI, 1.08-3.65). The McMaster GRADE Centre vetted and retained researchers to conduct systematic reviews of evidence and coordinate the guideline-development process, including the use of the GRADE approach. They recommended against the use of aspirin or anticoagulants. 0000024598 00000 n The EtD table addressed effects of interventions, resource utilization (cost-effectiveness), values and preferences (relative importance of outcomes), equity, acceptability, and feasibility. The guideline panel also explicitly took into account the extent of resource use associated with alternative management options. Blood Adv. For this recommendation, there was only 1 RCT with 43 participants and very few events (1 death, 1 PE, 3 DVTs). If symptomatic DVT develops, the potential impact is high. 0000012853 00000 n 0000003095 00000 n In Part B, they disclosed interests that were not mainly financial. Overall, the certainty in these estimated effects was very low owing to the risk of bias, the indirect comparison, and imprecision of the estimates. Other purposes are to inform policy, education, and advocacy and to state future research needs. UHL Guideline for Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in adults, with Direct Oral Anti-Coagulants Trust Ref B11/2018 1.Introduction and Who Guideline applies to The introduction of the Direct Oral Anti-Coagulants (DOACs) represents a major change in … The panel discussed which acutely ill medical inpatients should be considered in these guidelines. 0000004189 00000 n The ACCP advised not to use prophylaxis in medical patients at low risk of VTE, based on the Padua Prediction Score, or at high risk of bleeding. We found 17 systematic reviews that addressed this question,51-54,54-67  with 25 studies29,30,68-89  (H. Vissinger and S. Husted, unpublished data, 1995) in these reviews evaluating outcomes relevant to this question. 0000008698 00000 n The panel assumed that avoidance of death, PE, DVT, and major bleeding was critical to patients. Explanations and other considerations. The 95% CIs for these absolute effects using baseline risks from Spencer et al were 0 to 4 more per 1000 and 2 to 22 more per 1000, respectively.142. For new reviews, risk for bias was assessed at the health outcome level using the Cochrane Collaboration’s risk for bias tool for randomized trials or nonrandomized studies. Death did not occur in any of the studies. CI, confidence interval; CCU, Coronary Care Unit; GFR, glomerular filtration rate; ICU, Intensive Care Unit; INR, international normalized ratio. In acutely ill medical patients, the American Society of Hematology (ASH) guideline panel suggests using UFH, LMWH, or fondaparinux rather than no parenteral anticoagulant (conditional recommendation, low certainty in the evidence of effects ⊕⊕◯◯). In people who are at substantially increased VTE risk (eg, recent surgery, prior history of VTE, postpartum women, active malignancy, or ≥2 risk factors, including combinations of the above with hormone replacement therapy, obesity, or pregnancy), the ASH guideline panel suggests using graduated compression stockings or prophylactic LMWH for long-distance (>4 hours) travel (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). For mortality, the RR was 0.43 (95% CI, 0.14-1.31), and the ARR was 119 fewer per 1000 (180 fewer to 65 more per 1000). The outcomes rated highly by the panel and those identified as important based on the literature reviews were further refined. Introduction-GRADE evidence profiles and summary of findings tables, GRADE: an emerging consensus on rating quality of evidence and strength of recommendations, Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations, GRADE Guidelines: 16. Two studies115,117  assessed the risk of major bleeding, and 1 study assessed the risk of thrombocytopenia.115  No studies reported the outcome of HIT specifically. The panel suggested that future research should address: DOAC use among medical inpatients or for extended prophylaxis after discharge in larger trials assessing symptomatic VTE and bleeding end points, and in more selected patients based on predicted risk of VTE and of bleeding; and, Evaluation of lower-dose DOAC regimens in medical inpatients or for extended use after discharge, to determine whether this might mitigate bleeding risk while preventing VTE.143. For patients with acute DVT, the guideline recommends against the use of compression stockings routinely to prevent the post-thrombotic syndrome (Grade 2B). Worldwide, 3.4 billion passengers traveled by air in 2015 (http://data.worldbank.org/indicator/IS.AIR.PSGR). Question: Should mechanical VTE prophylaxis vs no VTE prophylaxis be used in acutely or critically ill medical patients? %PDF-1.5 %���� The panel judged that costs were negligible, and heparin prophylaxis was acceptable and feasible. form of treatment. On occasion, a strong recommendation is based on low or very low certainty in the evidence. For questions addressing mechanical approaches to VTE prophylaxis, we defined mechanical prophylaxis broadly as including pneumatic compression devices or graduated compression stockings. For distal DVT with a baseline risk of 1.4%, the ARR was 2 fewer per 1000 (95% CI, 6 fewer to 4 more per 1000). Overall, the certainty in these estimated effects is very low owing to very serious indirectness and serious risk of bias for the estimates (see evidence profile and online EtD framework). This document may also serve as the basis for adaptation by local, regional, or national guideline panels. 0000027983 00000 n Bleeding did not occur with LMWH or aspirin in the 1 available RCT. For DVT, the RR was 0.87 (95% CI, 0.60-1.25). The work of this panel was coordinated with 9 other guideline panels (addressing other aspects of VTE) by ASH and the McMaster GRADE Centre (funded by ASH under a paid agreement). The panel agreed on the recommendations (including direction and strength), remarks, and qualifications by consensus or, in rare instances, by voting (an 80% majority was required for a strong recommendation), based on the balance of all desirable and undesirable consequences. Intermittent pneumatic compression stockings vs graduated compression stockings, 12. International Travel and Health. There were no future research needs prioritized by the panel. DVT is more common than pulmonary embolism during pregnancy1 and will constitute the focus of this clinical update. A systematic review, Venous thrombosis risk assessment in medical inpatients: the medical inpatients and thrombosis (MITH) study, A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score, Predictive and associative models to identify hospitalized medical patients at risk for VTE, Multicentre validation of the Geneva Risk Score for hospitalised medical patients at risk of venous thromboembolism. These 3 recommendations also apply to anticoagulant choices when VTE prophylaxis be used framework is shown at https //dbep.gradepro.org/profile/0F91C482-0EC7-18AC-8738-817C23635ED2... In most situations suffering from an immediately life-threatening condition admitted to an intensive critical... Not clear that patients with prior VTE are particularly susceptible to air VTE., factor V Leiden, lupus anticoagulant, protein C, or both and managing venous thromboembolic ( )... 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