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In these settings, estimates of the benefits of prophylaxis were based upon related surgical settings, such as general surgical procedures and hip fracture surgery, respectively. We rated the overall certainty in the evidence of effects as very low based on the lowest certainty in the evidence for the critical outcomes, downgrading for study limitations, inconsistency, and indirectness. The risk of symptomatic distal DVTs may be reduced (RR, 0.66; 95% CI, 0.50-0.86; very low certainty in the evidence of effects), but we are uncertain of this. Pharmacological prophylaxis vs no pharmacological prophylaxis, 19. A double-blind, randomised, multicentre comparison. From RCTs, pharmacological prophylaxis may increase major bleeding (RR, 1.57; 95% CI, 0.70-3.50; low certainty in the evidence of effects), corresponding to 10 more (5 fewer to 43 more) events per 1000 patients undergoing major neurosurgical procedures. Development of these guidelines was wholly funded by ASH, a nonprofit medical specialty society that represents hematologists. Pharmacological prophylaxis may not reduce overall mortality compared with no pharmacological prophylaxis (RR, 0.75; 95% CI, 0.61 to 0.93; low certainty in the evidence of effects). The panel acknowledges that the overall certainty in the evidence was very low, given the issue of indirectness, with most of the available trial data not being specific to gynecological procedures. This corresponds to 2 fewer (0-4 fewer) symptomatic proximal DVTs and 0 fewer symptomatic distal DVTs with the use of LMWH than with warfarin for 1000 patients treated, based on baseline risks of 0.6% and 0.049%, respectively, from observational data.202,203. Pharmacological prophylaxis probably results in no difference in reoperations (RR, 2.01; 95% CI, 0.29-14.05; low certainty in the evidence of effects), corresponding to 1 more (1 fewer to 19 more) per 1000 patients. The panel based its recommendation on the judgment that the desirable benefits and the risk of complications were balanced between use of LMWH and UFH pharmacological prophylaxis. This would be expected to result in 6 more (3 fewer to 20 more) major bleeds per 1000 patients. Based on 1 large observational study383  and supported by a single relevant RCT,381  the rates of major bleeding may be increased with pharmacological prophylaxis (RR, 1.26; 95% CI, 1.07-1.47; low certainty in the evidence of effects). treatment with anticoagulation for at least 3 months over treatment of a shorter duration (Grade 1B), and we recommend treatment with anticoagulation for 3 months over treatment of a longer time-limited period (eg, 6, 12, or 24 months) (Grade 1B). In contrast, for patients at high risk for major bleeding, the large undesirable consequences of major bleeding led to a balance that favors no pharmacological prophylaxis. Six studies186-191  reported the effect of early vs late postsurgical antithrombotic administration on the risk of major bleeding and on the risk of reoperation. This 10th-edition guideline update is referred to as AT10.1One of the most notable changes in the updated guideline is the recommended choice of anticoagulant in patients with acute DVT or PE without c… For patients undergoing major surgery who do not receive pharmacologic prophylaxis, the ASH guideline panel suggests using mechanical prophylaxis over no mechanical prophylaxis (conditional recommendation based on very low certainty in the evidence of effects ⊕◯◯◯). An international multicentre trial, Dihydroergotamine-heparin prophylaxis of postoperative deep vein thrombosis. There may be a reduction in symptomatic PEs (RR, 0.40; 95% CI, 0.25-0.65; low certainty in the evidence of effects) favoring combined prophylaxis. Implementation of the guidelines will be facilitated by the related interactive forthcoming decision aids. Five studies assessed the effects of dabigatran,191,205-208  15 studies assessed the effects of rivaroxaban,180,185,189,190,199,209-218  4 studies assessed the effects of apixaban,219-222  5 studies assessed the effects of darexaban223-226  and edoxaban,227-231  and 4 studies assessed the effects of other DOACs.232-235, Thirty-four studies reported mortality,180,185,189-191,199,205-215,218-222,224-231,233-235  whereas 33 studies reported nonfatal PEs.180,185,189-191,199,205-212,214-216,219-222,224-231,233-235  We estimated proximal and distal DVTs using the pooled estimate from symptomatic DVTs, which was reported in 30 studies.185,189-191,199,205-212,214-216,219-222,224-230,234,235  Thirty-two studies reported major bleeding,180,185,189-191,205-212,214,215,219-222,224-235  whereas only 15 studies reported bleeding leading to reoperation.180,185,189-191,205-207,209-212,215,220,221. A randomized trial comparing graduated compression stockings alone or graduated compression stockings plus intermittent pneumatic compression with control, Thrombosis prophylaxis using external compression, Prevention of venous thrombosis after coronary artery bypass surgery (a randomized trial comparing two mechanical prophylaxis strategies), Prevention of thromboembolic disease by external pneumatic compression in patients undergoing total hip arthroplasty, Effect of mechanical compression on the prevalence of proximal deep venous thrombosis as assessed by magnetic resonance venography, Prevention of deep-vein thrombosis after total hip and knee replacement. We rated the overall certainty in the evidence of effects as very low based on the lowest certainty in the evidence for the critical outcomes and downgrading for study limitations, indirectness, and imprecision. Our update of the systematic review did not identify any additional studies that fulfilled the inclusion criteria. Blood Adv 2019; 3 (23): 3898–3944. A dose finding study (ONYX-2), Darexaban for the prevention of venous thromboembolism in Asian patients undergoing orthopedic surgery: results from 2 randomized, placebo-controlled, double-blind studies, Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V, Safety and efficacy of edoxaban in patients undergoing hip fracture surgery, Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan, Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial, Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. For patients who receive mechanical prophylaxis, using intermittent compression devices over graduated compression stockings (conditional recommendation based on very low certainty in the evidence of effects ⊕◯◯◯). We identified 11 systematic reviews addressing, in part, this question.23-33  We identified 38 studies in this review that fulfilled our inclusion criteria and measured outcomes relevant to this context.34-72  Our systematic search of randomized controlled trials (RCTs) identified 2 additional studies not included in previous systematic reviews and that fulfilled the inclusion criteria.70,72, Fifteen studies reported the effect of the pharmacological prophylaxis compared with mechanical prophylaxis alone on risk of mortality.35,36,40,42,51,54,57,59-61,63-65,68,72  Thirteen studies reported the effect on the development of symptomatic PEs,35,37,39,43,45,62,64,67-72  and 17 studies reported the effect on the development on any PE.34,36,38,40,42,46,47,50,51,53,58,60,61,63,67,71  Six studies reported data on symptomatic DVTs,35,67,69-72  and 17 studies reported data on any proximal DVT.34,35,37,39,41,45,52,53,57,58,64,65,67,69-72  Four studies reported data on symptomatic distal DVTs,35,70-72  and 16 studies reported data on any distal DVT.34,35,37,39,40,45,52,53,57,58,63,64,66,67,71,72, Eighteen studies reported the effect of pharmacological prophylaxis compared with mechanical prophylaxis alone on the risk of major bleeding,35-37,41,42,43,48,51,54,59-61,63-66,68,72, and 6 studies reported the effect on the risk of reoperation.37,42,46,48,54,72. Twenty-two studies in this review fulfilled our inclusion criteria. The 2011 AAOS guideline does not specifically address hip fractures; however, in the face of hip arthroplasty as a treatment for hip fracture, their recommendations of some form of chemoprophylaxis (including ASA), along with intermittent pneumatic compression for total hip arthroplasty, would be applicable.402  The 2012 Asian Venous Thromboembolism Guideline recommended LMWH, fondaparinux, rivaroxaban, apixaban, edoxaban, dabigatran, warfarin, or ASA with intermittent pneumatic compression.408  The Agency for Healthcare Research and Quality 2017 guideline favors chemoprophylaxis but is neutral on specific agents because of a lack of evidence.236  The 2013 International Angiology Guideline favors LMWH, fondaparinux, VKAs, or low-dose UFH.403  The most current NICE guideline recommends LMWH or fondaparinux.401, For general and abdominal surgery, which includes gastrointestinal, urological, gynecological, bariatric, vascular, plastic, or reconstructive surgery in its scope, the 2012 ACCP guidelines are once again the best known. The guideline panel determined that there is moderate certainty evidence for a net health benefit/harm from using LMWH over UFH. The systematic review found that there may be no difference in mortality between pharmacological and mechanical prophylaxis (relative risk [RR], 0.92; 95% confidence interval [CI], 0.46-1.84; low certainty in the evidence of effects); this corresponds to 1 fewer (5 fewer to 7 more) death per 1000 patients. We are also uncertain of the effect of early prophylaxis on symptomatic proximal DVTs (RR, 0.88; 95% CI, 0.40-1.96; very low certainty in the evidence of effects), corresponding to 2 fewer (10 fewer to 16 more) to 3 fewer (16 fewer to 25 more) per 1000 patients when applying baseline risks of 1.6% and 2.6%, respectively.73  Early prophylaxis has an uncertain effect on distal DVTs (RR, 0.68; 95% CI, 0.41-1.12; very low certainty in the evidence of effects), with an absolute risk reduction from 0 fewer (0-1 fewer; baseline risk, 0.1%73 ) to 1 fewer (0-1 fewer; baseline risk, 0.2%73 ) symptomatic distal DVT per 1000 patients. Again, given the very low baseline risks, this would correspond to 0 fewer (0 fewer to 0 more) events per 1000 patients for both outcomes. The evidence base to inform the relative effectiveness of pharmacological prophylaxis vs no pharmacological prophylaxis was comparable to that used to inform this question for patients undergoing laparoscopic cholecystectomy (see Recommendation 18). A double-blind, randomised trial, Postoperative deep vein thrombosis of the lower limb and prophylactic value of heparin evaluated by phlebography, Clinical and haemostatic parameters related to thromboembolism and low-dose heparin prophylaxis in major surgery, Prevention of postoperative thromboembolic disease in general surgery: a randomized trial of 2 therapeutic procedures evaluated by the labelled fibrinogen method [in French], Prophylaxis of postoperative deep vein thromboses by means of weak doses of subcutaneous heparin [in French], Effects of fixed minidose warfarin on coagulation and fibrinolysis following major gynaecological surgery, Necessity of routine postoperative heparinization in non-risky live-donor renal transplantation: results of a prospective randomized trial, The prophylazis of deep vein thrombosis with low-dose heparin: a trial, Failure of low-dose heparin to improve efficacy of peroperative intermittent calf compression in preventing postoperative deep vein thrombosis, Prophylaxis of postoperative leg vine thrombosis by low dose subcutaneous heparin or peroperative calf muscle stimulation: a controlled clinical trial, Low-dose heparin prophylaxis against fatal pulmonary embolism, Small heparin doses as prophylaxis against deep-vein thrombosis in major surgery, Hemorrhages caused by “low dose” heparin and placebo (NaCl solution) in surgical gynecology [in German], Prevention of postoperative deep-vein thrombosis with perioperative subcutaneous heparin, Low molecular weight heparin versus unfractionated heparin for perioperative thromboprophylaxis in patients with cancer, Comparison of low molecular weight heparin CY 216 and unfractionated heparin in preventing post-operative venous thromboembolism in general surgery: a preliminary results of a cooperative study, Prevention of postoperative deep vein thrombosis by one daily injection of low molecular weight heparin and dihydroergotamine, Comparison of enoxaparin and standard heparin in gynaecologic oncologic surgery: a randomised prospective double-blind clinical study, Efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep vein thrombosis in elective cancer surgery: a double-blind randomized multicentre trial with venographic assessment, Thromboprophylactic effect of low molecular weight heparin started in the evening before elective general abdominal surgery: a comparison with low-dose heparin, Low molecular weight heparin once daily compared with conventional low-dose heparin twice daily. Fifteen studies118,125,273-275,277,282,285,287,293,295,297,298,349,354  reported the effect of pharmacological prophylaxis vs no pharmacological prophylaxis on risk of major bleeding, and 6 studies38,118,275,282,295,354  reported the effect on risk of reoperation. There is likely no difference in mortality between combined prophylaxis and mechanical prophylaxis alone (RR, 1.24; 95% CI, 0.67-2.30; moderate certainty in the evidence of effects), corresponding to 3 more (4 fewer to 17 more) deaths per 1000 patients. The panel was particularly interested in seeing future high-quality studies of early vs late pharmacological prophylaxis studies in high-risk bleeding patients, examining the benefits and risks of later intervention (days following surgery) once the bleeding risk had greatly subsided. These might be considered “unmeasured harms” of mechanical prophylaxis. Surgical procedures carrying the highest risk of developing postoperative VTE include hip and knee arthroplasty, invasive neurosurgical procures, and major vascular procedures.9, Patient factors that carry greater risks for thrombosis include histories of VTE, particularly if unprovoked or associated with cancer, or cancer, even in the absence of previous VTE. A double-blind, prospective, randomized and mono-center study [in German]. In most circumstances, these innovations would be expected to reduce the overall risk of postoperative VTEs. critically reviewed the manuscript and provided suggestions for improvement; members of the knowledge synthesis team (G.P.M., T.B., S.B., J.L.B., I.E.-I., H.J., I.N., W.W., J.J.Y.-N., and H.J.S.) We are uncertain about the effect of pharmacological prophylaxis on mortality following major trauma (RR, 0.95; 95% CI, 0.84-1.07; very low certainty in the evidence of effects). For patients undergoing major surgery, the ASH guideline panel suggests using early or delayed antithrombotic prophylaxis (conditional recommendation based on very low certainty in the evidence of effects ⊕◯◯◯). This corresponds to 6 more (3 fewer to 20 more) major bleeding events per 1000 patients undergoing radical prostatectomy. • Patients with established deep vein thrombosis (DVT). The panel based its recommendation on RR ratios from meta-analysis of RCTs rather than observational studies, given the greater risk of bias with the latter studies. The panel recognizes that most of the evidence about the effectiveness comes from orthopedics (elective hip and knee arthroplasty). When DVT is confirmed, anticoagulation is indicated to control symptoms, prevent progression and reduce the risk of post‐thrombotic syndrome and pulmonary embolism. The risks of bleeding may be similar with LMWH and UFH (RR, 0.97; 95% CI, 0.78-1.20; low certainty in the evidence of effects), corresponding to 0 fewer (4 fewer to 3 more) major bleeding events per 1000 patients undergoing radical prostatectomy. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. In addition to synthesizing evidence systematically, the McMaster GRADE Centre supported the guideline-development process, including determining methods, preparing agendas and meeting materials, and facilitating panel discussions. For patients undergoing major gynecological surgery, the ASH guideline panel suggests using LMWH or UFH (conditional recommendation based on very low certainty in the evidence of effects ⊕◯◯◯). For patients undergoing surgery, the ASH guideline panel suggests using any of the DOACs approved for use (conditional recommendation based on low certainty in the evidence of effects ⊕⊕◯◯). 116. An evaluation of the conditions and criteria (and the related judgments, research evidence, and additional considerations) that determined the conditional (rather than strong) recommendation will help to identify possible research gaps. The panel chair was a content expert. Question: Should pharmacological prophylaxis vs no pharmacological prophylaxis be used for patients undergoing cardiac or major vascular surgery? The American Academy of Family Physicians endorsed these guidelines in March 2019 and provided the following key recommendations from the guidelines. For most patients undergoing TURP, the panel recommended against the use of pharmacological prophylaxis (see Recommendation 21). Question: Should pharmacological prophylaxis vs no pharmacological prophylaxis be used for patients experiencing major trauma? Prophylaxis of thromboembolism in elective abdominal surgery. We identified 1 systematic review that addressed this question.236  We identified 7 trials in this review that fulfilled our inclusion criteria and measured outcomes relevant to this context.39,219,237-241  Our systematic search of RCTs did not identify any additional study that fulfilled the inclusion criteria. We rated the overall certainty in the evidence of effects as moderate based on the lowest certainty in the evidence for the critical outcomes, downgrading for imprecision. The EtD framework is available online at https://guidelines.gradepro.org/profile/79bce70d-c689-4fbf-b0e4-c2ec3142bb2c. Lack of information regarding out-of-hospital use of pneumatic compression was a limitation of this technique. For patients at high baseline risk for major bleeding, mechanical prophylaxis would more clearly be favored because of the incremental risk of bleeding with pharmacological prophylaxis. The panel further judged the costs associated with pharmacological prophylaxis to be moderate based on very low certainty in the evidence about resource requirements. Continuing or intrinsic risk factors include: A history of DVT. The evidence base to inform the relative effectiveness of pharmacological prophylaxis vs no pharmacological prophylaxis was comparable to that used to inform this question for patients undergoing laparoscopic cholecystectomy (see Recommendation 18). Risks, values, and feasibility were not mainly financial to 3 more major... Panel and led the panel judged that there was possibly important uncertainty or variability in how much affected individuals the. Studies outside the field of orthopedics would be acceptable to stakeholders and are feasible to implement for some stakeholders decision-making... Heart J 2019 ; Aug 31: [ Epub ahead of print ] not reflect standard Practice in centers. 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( 10 ): 698-707 the included studies reported no events in either group in relative... Considered as high priority by the panel recognized that the balance of )... Or malignancy ) may benefit from pharmacological prophylaxis vs no pharmacological prophylaxis rated the magnitude of patient... Warfarin for patients undergoing TURP as trivial and the GRADE Centre hazards, such comparative,.

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January 9, 2021