Primary studies included in this systematic review

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PURPOSE: Venous thromboembolism (VTE) is a frequent and serious problem in intensive care units (ICU). Anticoagulant treatments have demonstrated their efficacy in preventing VTE. However, when the bleeding risk is high, they are contraindicated, and mechanical devices are recommended. To date, mechanical prophylaxis has not been rigorously evaluated in any trials in ICU patients. METHODS: In this multicenter, open-label, randomized trial with blinded evaluation of endpoints, we randomly assigned 407 patients with a high risk of bleeding to receive intermittent pneumatic compression (IPC) associated with graduated compression stockings (GCS) or GCS alone for 6 days during their ICU stay. The primary endpoint was the occurrence of a VTE between days 1 and 6, including nonfatal symptomatic documented VTE, or death due to a pulmonary embolism, or asymptomatic deep vein thrombosis detected by ultrasonography systematically performed on day 6. RESULTS: The primary outcome was assessed in 363 patients (89.2%). By day 6, the incidence of the primary outcome was 5.6% (10 of 179 patients) in the IPC + GCS group and 9.2% (17 of 184 patients) in the GCS group (relative risk 0.60; 95% confidence interval 0.28-1.28; p = 0.19). Tolerance of IPC was poor in only 12 patients (6.0%). No intergroup difference in mortality rate was observed. CONCLUSIONS: With the limitation of a low statistical power, our results do not support the superiority of the combination of IPC + GCS compared to GCS alone to prevent VTE in ICU patients at high risk of bleeding.

Primary study

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Journal Journal of thrombosis and haemostasis : JTH
Year 2012
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BACKGROUND: Patients undergoing neurosurgical procedures are at risk of venous thromboembolism (VTE), but often have contraindications for anticoagulant prophylaxis. OBJECTIVES: To assess the efficacy and tolerability of a new, lightweight, portable, battery-powered, intermittent calf compression device, Venowave, for the prevention of VTE in neurosurgical inpatients. PATIENTS/METHODS: We performed an open randomized controlled trial comparing Venowave with control for the prevention of VTE in patients undergoing neurosurgery. The primary outcome was the composite of asymptomatic deep vein thrombosis (DVT) detected by screening venography or compression ultrasound performed on day 9 (± 2 days) and symptomatic VTE. RESULTS: We randomized 75 patients to receive Venowave devices and 75 to the control group. All patients were prescribed graduated compression stockings and physiotherapy. VTE occurred in three patients randomized to Venowave and in 14 patients randomized to control (4.0% vs. 18.7%, relative risk 0.21; 95% confidence interval 0.05-0.75, P = 0.008). Similar reductions were seen for proximal DVT (2.7% vs. 8.0%) and symptomatic VTE (0% vs. 2.7%), and the results were consistent in all subgroups examined. CONCLUSIONS: Venowave devices are effective in preventing VTE in high-risk neurosurgical patients.

Primary study

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Journal International orthopaedics
Year 2011
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Deep-vein thrombosis (DVT) and pulmonary embolism (PE) represent life-threatening postoperative complications frequently responsible for in-hospital mortality following total knee arthroplasty (TKA). Mechanical prophylaxis in the form of a foot pump offers an alternative to pharmacological and physical therapy. The aim of this prospective and randomised study was to examine the clinical efficacy of the A-V Impulse (AVI) system in reduction of soft-tissue swelling of the lower limb following a TKA. A total of 80 patients undergoing cemented TKA between September 2005 and December 2006 were randomised into two groups of 40 patients (n¹ = 40, n² = 40) during the 16-month study period. All patients received a subcutaneous dose of low molecular weight heparin (LMWH) (Enoxaparin/Clexane® 40 mg) once daily beginning 24 hours prior to the operation. The mean age for the groups n¹ and n² were 68.93 and 68.15 years, respectively. The reduction of soft-tissue swelling in the n¹ group was significantly higher (p < 0.05) compared with n². Evaluation of body mass index (BMI) with regard to the average reduction of soft-tissue swelling showed no significant influence (p < 0.05). The better function of the operated knee in group AVI was a significant predictor for improved agility and mobility (p < 0.01). No complications were reported for the application of the AVI. No ultrasonographic evidence of DVT or PE was found in any of the 80 patients during the investigative time period of eight days. After three months, there was no evidence of a symptomatic DVT.

Primary study

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Journal Zhongguo wei zhong bing ji jiu yi xue = Chinese critical care medicine = Zhongguo weizhongbing jijiuyixue
Year 2011
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OBJECTIVE: To evaluate the efficacy of intermittent pneumatic compression (IPC) in the prevention of venous thromboembolism (VTE) in medical critically ill patients. METHODS: A prospective, randomized, controlled study was conducted. One hundred and sixty-two medical critically ill patients were randomly assigned to IPC group and control group by random number table after admitted to intensive care unit (ICU) from June 2008 to June 2010. Patients under anticoagulation medicine therapy were excluded. Patients in the IPC group were treated with IPC to prevent VTE after ICU admission. No measures were taken to prevent VTE in the control group. The rate of VTE [deep vein thrombosis (DVT) and pulmonary embolism (PE)], duration of mechanical ventilation(MV), the length of stay in ICU, rate of non-sudden cardiac death and ICU mortality rate and related side-effects of IPC were compared during the subsequent 28 days between two groups. RESULTS: Compared with control group, IPC group was shown to have a significantly lower rate of DVT [3.80%(3/79) vs. 19.28%(16/83), P<0.01], lower rate of PE [0 (0/79) vs. 9.64%(8/83), P<0.01] and lower rate of non-sudden cardiac death [1.26%(1/79) vs. 7.23%(6/83), P<0.01]. Compared with control group, duration of MV (days: 8±6 vs. 9±8) and length of stay in ICU (days: 9±7 vs. 10±7) were shorter, and the ICU mortality rate of 28 days (24.05% vs. 31.32%) was lower in the IPC group, but they were not statistically significant (all P>0.05). No related side-effects were found in the IPC group. CONCLUSION: IPC can prevent VTE, and lower the rate of non-sudden cardiac death, and it is safe in medical critically ill patients.

Primary study

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Journal Orthopedic nursing
Year 2011
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INTRODUCTION: : Prevention of venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been at the forefront of orthopaedic care for many years for lower extremity arthroplasty, which is at high risk for VTE. Risk of bleeding increases in total hip arthroplasty (THA) with low-molecular-weight heparin (LMWH) prophylaxis. A mobile compression device (MCD) that allows patients to move freely in hospital and at home may be safer. HYPOTHESIS: : The study hypothesized that patients using MCD would have less major bleeding than patients using LMWH without affecting the efficacy of thrombosis prevention in THA. SAMPLE: : Following THA, 395 patients at 9 healthcare sites in the United States were randomized to receive either MCD or LMWH for VTE prophylaxis. METHODS: : A mobile compression device was applied in the operating room and continued for 10 days with or without aspirin 81 mg daily. Low-molecular-weight heparin was started the morning after surgery and continued for 10 days. Days 10-12 following surgery, bilateral duplex ultrasound was performed on all patients. Bleeding events were recorded during treatment and VTE events were recorded for 3 months. Number of hours of device use was recorded. FINDINGS: : Major bleeding events occurred in 11 patients, all in the LMWH group (6%). Venous thromboembolism occurrence was similar, 5.1% in the MCD group and 5.3% in the LMWH group. The MCD group used the device 83% of possible usable time. DISCUSSION: : Findings of significantly less major bleeding in the MCD group than the LMWH group supported our hypothesis with no significant difference in VTE.

Primary study

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Journal Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES
Year 2010
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BACKGROUND: We aimed to evaluate the efficacy and safety of low molecular weight heparin (LMWH) compared to elastic stockings in combination with intermittent pneumatic compression (ES+IPC) in venous thromboembolism (VTE) prophylaxis in the intensive care unit (ICU) of trauma and emergency surgery. METHODS: From June 2005 to June 2007, 259 patients who were on mechanic ventilation in the ICU were assigned to two groups as either LMWH (152 patients) or ES+IPC (94 patients). Color flow Doppler sonography was performed on the 3rd and 7th days. RESULTS: Deep venous thrombosis was determined in 3 (2%) of the LMWH group and in 1 (1%) in the ES+IPC group. Minor bleeding was seen in 15 patients. The frequency of VTE was 1.5%. Two patients suffered from fatal pulmonary embolism (PE) among a total of 4 patients with PE. CONCLUSION: We believe that the protocol applied for VTE prophylaxis in the Emergency Surgery Department of Istanbul Medical Faculty is effective and safe in this group with such high mortality and morbidity.

Primary study

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Auteurs Yang BL , Zhang ZY , Guo SL
Journal Zhonghua fu chan ke za zhi
Year 2009
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OBJECTIVE: To explore the clinical significance of preventive treatment of thrombosis for patients undergoing gynecological surgeries with high risk factors. METHODS: Prospectively, randomized and cases controlled study was performed in 143 patients underwent gynecological surgery with high risk factors to explore the prevention effectiveness and safety in morbidity of lower extremity deep venous thrombosis (LDVT) and relative effected factors, who were enrolled to three groups according to different preventive treatment: group using intermittent pneumatic calf compression (IPC) in 47 cases, group using low-molecular-weight hepairin (LMWH) in 48 cases and control group in 48 cases with no prevention strategy. RESULTS: The morbidity of LDVT on lower extremity was 6% (6/94) in group IPC and 1% (1/96) in group LMWH, 18% (17/96) in control group, which was obviously reduced in group IPC and group LMWH than that in control group (P < 0.05), while there was no significantly difference between group IPC and group LMWH (P > 0.05). After surgery in 3 or 4 days, the morbidity of LDVT in group IPC was 1/6, zero in group LMWH and 71% (12/17) in control group, there was significantly reduced in group IPC and group LMWH than that in control group (P < 0.05). There was no side-effects in group IPC, only 1 case in group LMWH presented small quantity bleed in vagina remnant, while no incision bleeding and bleed tendency. Single-variate analysis indicated that elder age, abdominal surgeries and malignant tumor were as the independent factors to effect preventive treatment of thrombosis (P < 0.05). CONCLUSION: LDVT in patients underwent gynecological surgeries with high risk factors can be obviously reduced and delayed by preventive treatment, which is no side-effects, while be effected by the factors of elder age, abdominal surgeries and malignant tumor.

Primary study

Unclassified

Auteurs Chin PL , Amin MS , Yang KY , Yeo SJ , Lo NN
Journal Journal of orthopaedic surgery (Hong Kong)
Year 2009
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<b>PURPOSE: </b>To compare the efficacy and safety of different modes of thromboembolic prophylaxis for elective total knee arthroplasty (TKA) in Asian patients. <b>METHODS: </b>440 low-risk patients undergoing TKA were randomised into 4 equal groups: (1) no prophylaxis (control), (2) graduated compression stockings (GCS), (3) intermittent pneumatic compression (IPC), and (4) low-molecular-weight heparin (enoxaparin). Duplex ultrasonography was used as an assessment tool. <b>RESULTS: </b>The deep vein thrombosis point prevalence was highest in the control group (22%), which was significantly higher than in patients receiving IPC (8%, p=0.032) or enoxaparin (6%, p=0.001). One patient each in the control and GCS groups developed a non-fatal pulmonary embolism. Patients on enoxaparin received more blood transfusions and 2 of them had major bleeding complications. <b>CONCLUSION: </b>IPC is the preferred method of thromboprophylaxis for TKA in Asian patients.

Primary study

Unclassified

Journal The Journal of arthroplasty
Year 2008
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This preliminary prospective study to determine the rate of deep venous thrombosis (DVT) examined 277 patients undergoing total knee or total hip arthroplasty (TKA or THA) who were randomized to use a portable, continuous enhanced circulation therapy (CECT) compression device and low-molecular-weight heparin (LMWH) or to receive LMWH alone. Patients were screened for DVT using duplex ultrasound at hospital discharge and followed clinically for 3 months. In TKA, 5 DVTs (6.6%) occurred in the CECT + LMWH group compared with one pulmonary embolism and 14 DVTs (19.5%) in the LMWH group (P = .018). In THA, 1 DVT (1.5%) occurred in the CECT + LMWH group and 2 DVTs (3.4%) occurred in the LMWH group. This preliminary study demonstrated significant reduction in rate of DVT after TKA when the CECT device was combined with LMWH.

Primary study

Unclassified

Auteurs Eisele R , Kinzl L , Koelsch T
Journal The Journal of bone and joint surgery. American volume
Year 2007
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CONTEXTE: Les régimes thérapeutiques actuels qui sont conçus pour prévenir la thrombose veineuse profonde chez les patients subissant des interventions orthopédiques comptent surtout sur la prophylaxie médicamenteuse seule. Le but de cette étude clinique randomisée était d'évaluer l'efficacité d'un complément à la chimioprophylaxie mécanique qui implique une compression intermittente des jambes. MÉTHODES: Au cours d'une période de vingt-deux mois, 1803 patients subissant une variété de procédures orthopédiques ont été prospectivement randomisés pour recevoir soit la chimioprophylaxie seul ou une combinaison de la chimioprophylaxie et la prophylaxie mécanique. Neuf cent deux patients ont été gérées à bas poids moléculaire héparine seule, et 901 ont été gérées à bas poids moléculaire et l'héparine de compression pneumatique intermittente des veaux pour différentes périodes. Vingt-quatre pour cent des patients ont subi une prothèse totale de hanche ou de genou. Le dépistage de la thrombose veineuse profonde a été réalisée sur le jour de sortie en duplex-code couleur échographie. RÉSULTATS: Dans le groupe chimioprophylaxie seule, quinze patients (1,7%) ont été diagnostiqués avec une thrombose veineuse profonde; trois thromboses étaient symptomatiques. Dans la chimioprophylaxie, plus intermittente groupe de compression pneumatique, quatre patients (0,4%) ont été diagnostiqués avec une thrombose veineuse profonde; une thrombose était symptomatique. La différence entre les groupes en ce qui concerne la prévalence de la thrombose veineuse profonde était significative (p = 0,007). Dans la chimioprophylaxie, plus intermittente groupe de compression pneumatique, aucun thromboses veineuses profondes ont été trouvés chez les patients qui ont reçu plus de six heures de la compression pneumatique intermittente quotidienne. CONCLUSIONS: prophylaxie thrombose veineuse à faible poids moléculaire héparine complétée par un dispositif qui offre rapide de l'inflation compression pneumatique intermittente aux veaux a été jugé significativement plus efficace pour prévenir la thrombose veineuse profonde par rapport à une régime de traitement qui a impliqué de bas poids moléculaire -poids l'héparine seule.