Prolonged prophylaxis with dalteparin to prevent late thromboembolic complications in patients undergoing major abdominal surgery: a multicenter randomized open‐label study

Rasmussen, Morten; Jørgensen, Lars N.; Wille‐Jørgensen, Peer; Nielsen, Jannie; Horn, Arild; Mohn, Arne Christian; Sømod, L.; Olsen, Birthe Susanne

doi:10.1111/j.1538-7836.2006.02153.x

Cited by 348 publications

(226 citation statements)

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“…58, N o 5, octobre 2015 lost patients in either group could have had dramatic effects on the results either way. The FAME study 8 found a relative risk reduction of 55%, but again the number of patients who dropped out was significant. In a third study, the number of patients who were included in the outcome assessment was only one-third of the total.…”

Section: Discussionmentioning

confidence: 96%

“…However, the existing literature has not reported an increased bleeding risk, 8,[12][13][14]21 and the consequences of VTE can be lethal. In the Cochrane meta-analysis, 14 the rate of bleeding events in the treatment group was 4.1% (25 of 614 patients) compared with 3.7% (23 of 628 patients) in the control group.…”

Section: Discussionmentioning

confidence: 99%

“…We estimated that incidence of VTE after discharge would be about 1%. 8,12,14 In order to be 95% confident that the true incidence is within ± 1%, 381 patients needed to be included in the sample. Therefore our study had more than enough power to reach its primary objective.…”

Section: Discussionmentioning

confidence: 99%

“…[1][2][3][4] The risk persists after hospital discharge and after discontinuation of the usual perioperative thromboprophylaxis. [5][6][7][8][9][10][11] Only a few studies have evaluated the efficacy and safety of prolonged thromboprophylaxis with low molecular weight heparin (LMWH) after discharge from hospital in patients undergoing surgery for abdominal or pelvic cancer. In both the FAME 8 and ENOXACAN II 12 trials, substantial numbers of patients were left unaccounted for.…”

mentioning

confidence: 99%

“…[5][6][7][8][9][10][11] Only a few studies have evaluated the efficacy and safety of prolonged thromboprophylaxis with low molecular weight heparin (LMWH) after discharge from hospital in patients undergoing surgery for abdominal or pelvic cancer. In both the FAME 8 and ENOXACAN II 12 trials, substantial numbers of patients were left unaccounted for. Much of the benefit in the ENOXACAN II study was seen in distal deep vein thromboses (DVT) picked up on routine venography.…”

mentioning

confidence: 99%

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Diagnosis of VTE postdischarge for major abdominal and pelvic oncologic surgery: implications for a change in practice

et al. 2015

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Background: Extended thromboprophylaxis after hospital discharge following cancer surgery has been shown to reduce the incidence of venous thromboembolism (VTE); however, this practice has not been universally adopted. We conducted a populationbased analysis to determine the proportion of patients with symptomatic VTE diagnosed within 90 days after initial discharge following major abdominopelvic cancer surgery who might have benefited from extended thromboprophylaxis. Methods:We used the Manitoba Cancer Registry to identify patients who underwent major abdominopelvic cancer surgery between 2004 and 2009. The proportion in whom VTE was diagnosed during the initial hospital stay was determined by accessing the Hospital Separations Abstracts. The proportion in whom VTE was diagnosed after discharge was determined by examining repeat admissions within 90 days and by accessing Drug Programs Information Network records for newly prescribed anticoagulants. Detailed tumour and treatment-specific data allowed calculation of VTE predictors.Results: Of 6612 patients identified, 106 (1.60%) had VTE diagnosed during the in itial stay and 96 (1.45%) presented with VTE after discharge. Among patients in whom VTE developed after discharge, 33.3% had a pulmonary embolus, 24% had deep vein thrombosis, and 6.3% had both. Predictors of presenting with VTE after discharge within 90 days of surgery included advanced disease, presence of other complications, increased hospital resource utilization, primary tumours of noncolorectal gastrointestinal origin and age younger than 45 years. The development of VTE was an independent predictor of decreased 5-year overall survival. Conclusion:The cumulative incidence of VTE within 90 days of major abdominopelvic oncologic surgery was 3.01%, with about half (1.45%) having been diagnosed within 90 days after discharge.Contexte : La thromboprophylaxie prolongée après le congé hospitalier suite à une chirurgie pour cancer a permis de réduire l'incidence de la thrombo-embolie veineuse (TEV); or, cette pratique n'a pas été universellement adoptée. Nous avons procédé à une analyse de population afin de déterminer la proportion de patients qui ont reçu un diagnostic de TEV symptomatique dans les 90 jours suivant leur congé à la suite d'une chirurgie majeure pour cancer abdomino-pelvien et qui auraient pu bénéficier d'une thromboprophylaxie prolongée.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Diagnosis of VTE postdischarge for major abdominal and pelvic oncologic surgery: implications for a change in practice

et al. 2015

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Venous Thromboembolism Prevention in Emergency General Surgery

et al. 2018

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Despite the substantial number of annual EGS admissions, little is known about the risk of VTE or the use of mechanical and/or pharmacologic prophylaxis in EGS patients. Furthermore, although guidelines for VTE prophylaxis are available, 10,11 they are difficult to interpret in the context of admission to an EGS service for an acute condition, particularly when admissions to such services include as many as 70% of patients who do not require operative intervention. 9 The purpose of this narrative review is to apply the existing literature on VTE prophylaxis to this challenging group of EGS patients and offer recommendations using the best available evidence. MethodsWe performed an electronic literature search of MEDLINE, EMBASE, and the Cochrane Database of Collected Reviews from January 1, IMPORTANCE Venous thromboembolism (VTE) is the most preventable cause of morbidity and mortality in US hospitals, and approximately 2.5% of emergency general surgery (EGS) patients will be diagnosed with a VTE event. Emergency general surgery patients are at increased risk of morbidity and mortality because of the nature of acute surgical conditions and the challenges related to prophylaxis.OBSERVATIONS MEDLINE, Embase, and the Cochrane Database of Collected Reviews were searched from January 1, 1990, through December 31, 2015. Nearly all operatively and nonoperatively treated EGS patients have a moderate to high risk of developing a VTE, and individual risk should be assessed at admission. Pharmacologic prophylaxis in the form of unfractionated or low-molecular-weight heparin should be considered unless an absolute contraindication, such as bleeding, exists. Patients should receive the first dose at admission to the hospital, and administration should continue until discharge without missed doses. Certain patient populations, such as those with malignant tumors, may benefit from prolonged VTE prophylaxis after discharge. Mechanical prophylaxis should be considered in all patients, particularly if pharmacologic prophylaxis is contraindicated. Studies that specifically target improved adherence with VTE prophylaxis in EGS patients suggest that efficacy and quality improvement initiatives should be undertaken from a system and institutional perspective.CONCLUSIONS AND RELEVANCE Operatively and nonoperatively treated EGS patients are at a comparatively high risk of VTE. Despite gaps in existing literature with respect to this increasing patient population, successful best practices can be applied. Best practices include assessment of VTE risk, optimal prophylaxis, and physician, nurse, and patient education regarding the use of mechanical and pharmacologic VTE prophylaxis and institutional policies.

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Assessment of Anti–Factor Xa Levels of Patients Undergoing Colorectal Surgery Given Once-Daily Enoxaparin Prophylaxis

et al. 2019

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IMPORTANCE Between 4% and 12% of patients undergoing colorectal surgery and receiving enoxaparin, 40 mg per day, have a postoperative venous thromboembolism (VTE) event. An improved understanding of why "breakthrough" VTE events occur despite guideline-compliant prophylaxis is an important patient safety question. OBJECTIVE To determine the proportion of patients undergoing colorectal surgery who received adequate anticoagulation based on peak anti-factor Xa (aFXa) levels while receiving enoxaparin at 40 mg per day. DESIGN, SETTING, AND PARTICIPANTS This prospective, nonrandomized clinical trial was conducted between February 2017 and July 2018 with 90-day follow-up at a quaternary academic medical center in the Intermountain West and included patients undergoing colorectal surgery who had surgery after receiving general anesthesia, were admitted for at least 3 days, and received enoxaparin, 40 mg once daily. INTERVENTIONS All patients had aFXa levels measured after receiving enoxaparin 40 mg per day. Patients whose aFXa level was out of range entered the trial's interventional arm where real-time enoxaparin dose adjustment and repeated aFXa measurement were performed. MAIN OUTCOMES AND MEASURES Primary outcome: in-range peak aFXa levels (goal range, 0.3-0.5 IU/mL) with enoxaparin, 40 mg per day. Secondary outcomes: (1) in-range trough aFXa levels (goal range, 0.1-0.2 IU/mL) and (2) the proportion of patients with in-range peak aFXa levels from enoxaparin, 40 mg once daily, vs the real-time enoxaparin dose adjustment protocol. RESULTS Over 16 months, 116 patients undergoing colorectal surgery (65 women [56.0%]; 99 white individuals [85.3%], 13 Hispanic or Latino individuals [11.2%], and 4 Pacific Islander individuals [3.5%]; mean [range] age, 52.1 [18-85] years) were enrolled. Among 106 patients (91.4%) whose peak aFXa level was appropriately drawn, 72 (67.9%) received inadequate anticoagulation (aFXa < 0.3 IU/mL) with enoxaparin, 40 mg per day. Weight and peak aFXa levels were inversely correlated (r 2 = 0.38). Forty-seven patients (77%) had a trough aFXa level that was not detectable (ie, most patients had no detectable level of anticoagulation for at least 12 hours per day). Real-time enoxaparin dose adjustment was effective. Patients were significantly more likely to achieve an in-range peak aFXa with real-time dose adjustment as opposed to fixed dosing alone (85.4% vs 29.2%, P < .001). CONCLUSIONS AND RELEVANCE This study supports the finding that most patients undergoing colorectal surgery receive inadequate prophylaxis from enoxaparin, 40 mg once daily. These findings may explain the high rate of "breakthrough" VTE observed in many clinical trials. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02704052

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Prolonged prophylaxis with dalteparin to prevent late thromboembolic complications in patients undergoing major abdominal surgery: a multicenter randomized open‐label study

Cited by 348 publications

References 22 publications

Diagnosis of VTE postdischarge for major abdominal and pelvic oncologic surgery: implications for a change in practice

Diagnosis of VTE postdischarge for major abdominal and pelvic oncologic surgery: implications for a change in practice

Venous Thromboembolism Prevention in Emergency General Surgery

Assessment of Anti–Factor Xa Levels of Patients Undergoing Colorectal Surgery Given Once-Daily Enoxaparin Prophylaxis

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