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Doruk Erkan - One of the best experts on this subject based on the ideXlab platform.
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hydroxychloroquine in the primary Thrombosis prophylaxis of antiphospholipid antibody positive patients without systemic autoimmune disease
2018Co-Authors: Doruk Erkan, Ware D Branch, Jason S Knight, Ozan Unlu, Savino Sciascia, H M Belmont, M J Cuadrado, Emilio B Gonzalez, Imad Uthman, Rohan WillisAbstract:Objective The objective of this study was to determine the efficacy of hydroxychloroquine (HCQ) in the primary Thrombosis Prevention of antiphospholipid antibody (aPL)-positive patients with no other systemic autoimmune diseases. Methods Under the auspices of Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking, a multicenter, international, randomized controlled trial (RCT) was initiated, in which persistently aPL-positive but Thrombosis-free patients without systemic autoimmune diseases were randomized to receive HCQ or no treatment in addition to their standard regimen. The primary objective was the efficacy of HCQ in preventing the first Thrombosis. The secondary objectives were the Thrombosis incidence rate, and the effects of HCQ on aPL profile and mortality rate. Patients were risk-stratified based on antiplatelet agent use. The goal was to follow patients every 6 months for 5 years. Results We recruited 20 persistently aPL-positive patients (female: 19, mean age: 46.6 ± 9.9 years, and baseline antiplatelet medication: 14); 9/20 were randomized to HCQ. During the mean follow-up of 1.7 years, no patients developed Thrombosis or a serious adverse event. The study was terminated early due to the low recruitment rate, exacerbated by the prolonged manufacturing shortage and significant price increase of HCQ in the United States. Conclusion Given that a small number of patients with a relatively short follow-up were enrolled in our RCT, and no patients developed Thrombosis, we cannot accurately assess the effectiveness of HCQ for primary Thrombosis Prevention in persistently aPL-positive patients with no other systemic autoimmune diseases. Our experience suggests that conducting an international RCT, especially without pharmaceutical support, is an extremely challenging undertaking.
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aps action antiphospholipid syndrome alliance for clinical trials and international networking
2012Co-Authors: Doruk ErkanAbstract:AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking (APS ACTION) is the first-ever international research network that has been created specifically to design and conduct well-designed, large-scale, multi-center clinical trials in persistently antiphospholipid antibody (aPL)-positive patients. The founding principle of the APS ACTION is that it is an internationally collaborative effort, open to qualified investigators across the globe who are committed to furthering our understanding of APS and its management. Due to the hard work and collaborative spirit of APS ACTION members, in early 2012, APS ACTION launched two important collaborative international projects: 1) a randomized controlled trial of hydroxychloroquine in the primary Thrombosis Prevention of persistently aPL-positive but Thrombosis-free patients without other systemic autoimmune diseases; and 2) a web-based registry of aPL-positive patients with or without systemic autoimmune diseases, which will also include annual blood collection for aPL-testing and future basic science studies. In the end, we hope to find better treatments for antiphospholipid syndrome, which is a leading cause of Thrombosis, pregnancy morbidity and other life-altering consequences, and to heighten awareness about this life-threatening, autoimmune condition. Lupus (2012) 21, 695–698.
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primary Thrombosis prophylaxis in antiphospholipid antibody positive patients where do we stand
2011Co-Authors: Medha Barbhaiya, Doruk ErkanAbstract:Persistently positive antiphospholipid antibodies (aPLs) with Thrombosis and/or pregnancy morbidity are the hallmark of the antiphospholipid syndrome. However, aPL-positive patients with no prior history of Thrombosis exist. On the basis of a limited number of studies that predominantly included systemic lupus erythematosus patients, aPL-positive patients without previous Thrombosis have a 0% to 3.8% annual incident Thrombosis risk. Given that every positive aPL test is not clinically significant and every aPL-positive patient does not have the same Thrombosis risk, risk stratification (based on aPL profile, age, systemic autoimmune diseases, and traditional cardiovascular disease or venous Thrombosis risk factors) is crucial to determine the first Thrombosis risk in aPL-positive patients. The optimal primary Thrombosis Prevention strategy in patients with clinically significant aPL profiles should include 1) regular monitoring and elimination of non-aPL Thrombosis risk factors, 2) aggressive management of clinical and subclinical systemic autoimmune disease activity, and 3) patient counseling and education. The protective effect of low-dose aspirin against incident Thrombosis in patients with clinically significant aPL profiles is not supported by randomized controlled data; general population cardiovascular disease risk prediction tools and Prevention guidelines formulated based on risk–benefit calculations should play a role in the decision whether to recommend low-dose aspirin. The effectiveness of hydroxychloroquine, statins, or their combination remains to be determined by well-designed randomized controlled trials.
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aspirin for primary Thrombosis Prevention in the antiphospholipid syndrome a randomized double blind placebo controlled trial in asymptomatic antiphospholipid antibody positive individuals
2007Co-Authors: Doruk Erkan, Lisa R. Sammaritano, Michelle Petri, Roger A. Levy, Melanie J Harrison, Margaret G E Peterson, Aynur Unalparida, Veronica Silva Vilela, Yusuf Yazici, Michael D. LockshinAbstract:Objective To determine the efficacy of a daily dose of 81 mg aspirin in primary Thrombosis Prevention in asymptomatic, persistently antiphospholipid antibody (aPL)–positive individuals (those with positive aPL but no vascular and/or pregnancy events). Methods The Antiphospholipid Antibody Acetylsalicylic Acid (APLASA) study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in which asymptomatic, persistently aPL-positive individuals were randomized to receive a daily dose of 81 mg of aspirin or placebo. In a separate observational and parallel study, asymptomatic, persistently aPL-positive individuals who were taking aspirin or declined randomization were followed up prospectively. Results In the APLASA study, 98 individuals were randomized to receive aspirin or placebo (mean ± SD followup period 2.30 ± 0.95 years), of whom 48 received aspirin and 50 received placebo. In the observational study, 74 nonrandomized individuals were followed up prospectively (mean ± SD followup period 2.46 ± 0.76 years); 61 received aspirin and 13 did not. In the APLASA study, the acute Thrombosis incidence rates were 2.75 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for the placebo-treated subjects (hazard ratio 1.04, 95% confidence interval 0.69–1.56) (P = 0.83). Similarly, in the observational study, the acute Thrombosis incidence rates were 2.70 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for those not treated with aspirin. All but 1 patient with Thrombosis in either study had concomitant Thrombosis risk factors and/or systemic autoimmune disease at the time of Thrombosis. Conclusion Our results suggest that asymptomatic, persistently aPL-positive individuals do not benefit from low-dose aspirin for primary Thrombosis prophylaxis, have a low overall annual incidence rate of acute Thrombosis, and develop vascular events when additional Thrombosis risk factors are present.
Douglas E Padgett - One of the best experts on this subject based on the ideXlab platform.
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a mobile compression device for Thrombosis Prevention in hip and knee arthroplasty
2014Co-Authors: Clifford W Colwell, Mark I Froimson, Scott D Anseth, Nicholas J Giori, William G Hamilton, Robert L Barrack, Knute C Buehler, Michael A Mont, Douglas E Padgett, Pamela A PulidoAbstract:Background: Venous thromboembolic events, either deep venous Thrombosis or pulmonary embolism, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.) with or without aspirin compared with current pharmacological protocols for prophylaxis against venous thromboembolism in patients undergoing elective primary unilateral arthroplasty of a lower-extremity joint. Methods: A multicenter registry was established to capture the rate of symptomatic venous thromboembolic events following primary knee arthroplasty (1551 patients) or hip arthroplasty (1509 patients) from ten sites. All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous Thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous Thrombosis or pulmonary embolism. Results: Of 3060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thrombi, three proximal deep venous thrombi, and five pulmonary emboli). One death occurred, with no autopsy performed. Symptomatic venous thromboembolic rates observed in patients who had an arthroplasty of a lower-extremity joint using the mobile compression device were noninferior (not worse than), at a margin of 1.0%, to the rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran, except in the knee arthroplasty group, in which the mobile compression device fell short of the rate reported for rivaroxaban by 0.06%. Conclusions: Use of the mobile compression device with or without aspirin for patients undergoing arthroplasty of a lower-extremity joint provides a noninferior risk for the development of venous thromboembolism compared with current pharmacological protocols. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence. Peer Review This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
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Thrombosis Prevention after total hip arthroplasty a prospective randomized trial comparing a mobile compression device with low molecular weight heparin
2010Co-Authors: Clifford W Colwell, Mark I Froimson, Knute C Buehler, Michael A Mont, Douglas E Padgett, Merrill A Ritter, Robert T Trousdale, Andrew I Spitzer, Thomas K Donaldson, 勘武生 译Abstract:背景：血栓栓塞性疾病是全髋关节置换术后常见的并发症。本研究的目的在于比较新型便携式加压器与低分子量肝素在静脉血栓预防中的安全性和有效性。方法：全髋置换患者随机接受为期10d便携式加压器或者低分子量肝素预防治疗。术中开始使用加压器，并且这组患者在术后日服81mg的阿司匹林。使用肝素者，术后12-24h开始注射低分子量肝素。在10-12d后，所有患者行多普勒超声筛查双下肢小腿、大腿部深静脉血栓；有肺栓塞临床症状的患者均接受肺部螺旋CT扫描评价。记录两组出血和于预性治疗情况（即：依从性）。术后12周进行深静脉血栓和肺栓塞证据的临床评估。结果：410例患者（414髋）进行随机化分组；392例患者（395髋）进行手术安全性评估，386例（389髋）治疗结果有效。两组间的一般临床情况无差异。加压组严重出血发生率O％，低分子量肝素组6％。加压组远端和近端深静脉血栓发生率分别为3％、2％，肝素组3％、1％。肺栓塞发生率加压组1％，肝素组1％，无致命性肺栓塞。随访12周，1例加压组患者出现两项事件（深静脉血栓和肺栓塞），该患者术后第12天多普勒超声检查阴性。在静脉血栓栓塞预防上两组比较无明显差异。结论：全髋置换术后静脉血栓栓塞预防，便携式加压器与低分子量肝素比较，可明显减少严重出血。
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Thrombosis Prevention after total hip arthroplasty a prospective randomized trial comparing a mobile compression device with low molecular weight heparin
2010Co-Authors: Clifford W Colwell, Mark I Froimson, Knute C Buehler, Michael A Mont, Merrill A Ritter, Robert T Trousdale, Andrew I Spitzer, Thomas K Donaldson, Douglas E PadgettAbstract:Background: Thromboembolic disease is a common complication of total hip arthroplasty. The purpose of this study was to compare a new mobile compression device with low-molecular-weight heparin with regard to their safety and effectiveness for the Prevention of venous thromboembolic disease. Methods: Patients who had a total hip arthroplasty were randomized to receive prophylaxis with a mobile compression device or low-molecular-weight heparin for ten days. Use of the compression device began intraoperatively, and the patients in this group could receive 81 mg of aspirin daily after the surgery. The first injection of the low-molecular-weight heparin began between twelve and twenty-four hours after the surgery. After ten to twelve days, all patients underwent bilateral lower-extremity duplex ultrasonography to screen for deep venous thrombi in the calf and thigh. Any clinical symptoms of pulmonary embolism were evaluated with spiral computed tomography lung scans. Bleeding events and utilization of (i.e., compliance with) prophylactic treatment in both groups were documented. Clinical evaluation to look for evidence of deep venous thrombi and pulmonary emboli was performed at twelve weeks postoperatively. Results: Four hundred and ten patients (414 hips) were randomized; 392 of these patients (395 of the hips) were evaluable with regard to the safety of the intervention and 386 patients (389 hips) were evaluable with regard to its efficacy. Demographics were similar clinically between the groups. The rate of major bleeding events was 0% in the compression group and 6% in the low-molecular-weight heparin group. The rates of distal and proximal deep venous Thrombosis were 3% and 2%, respectively, in the compression group compared with 3% and 1% in the heparin group. The rates of pulmonary embolism were 1% in the compression group and 1% in the heparin group, and there were no fatal pulmonary emboli. Within the twelve-week follow-up period, two events (one deep venous Thrombosis and one pulmonary embolus) occurred in one patient in the compression group following negative findings on duplex ultrasonography on the twelfth postoperative day. There was no difference between the groups with regard to the prevalence of venous thromboembolism. Conclusions: When compared with low-molecular-weight heparin, use of the mobile compression device for prophylaxis against venous thromboembolic events following total hip arthroplasty resulted in a significant decrease in major bleeding events. Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.
Clifford W Colwell - One of the best experts on this subject based on the ideXlab platform.
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a mobile compression device for Thrombosis Prevention in hip and knee arthroplasty
2014Co-Authors: Clifford W Colwell, Mark I Froimson, Scott D Anseth, Nicholas J Giori, William G Hamilton, Robert L Barrack, Knute C Buehler, Michael A Mont, Douglas E Padgett, Pamela A PulidoAbstract:Background: Venous thromboembolic events, either deep venous Thrombosis or pulmonary embolism, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.) with or without aspirin compared with current pharmacological protocols for prophylaxis against venous thromboembolism in patients undergoing elective primary unilateral arthroplasty of a lower-extremity joint. Methods: A multicenter registry was established to capture the rate of symptomatic venous thromboembolic events following primary knee arthroplasty (1551 patients) or hip arthroplasty (1509 patients) from ten sites. All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous Thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous Thrombosis or pulmonary embolism. Results: Of 3060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thrombi, three proximal deep venous thrombi, and five pulmonary emboli). One death occurred, with no autopsy performed. Symptomatic venous thromboembolic rates observed in patients who had an arthroplasty of a lower-extremity joint using the mobile compression device were noninferior (not worse than), at a margin of 1.0%, to the rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran, except in the knee arthroplasty group, in which the mobile compression device fell short of the rate reported for rivaroxaban by 0.06%. Conclusions: Use of the mobile compression device with or without aspirin for patients undergoing arthroplasty of a lower-extremity joint provides a noninferior risk for the development of venous thromboembolism compared with current pharmacological protocols. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence. Peer Review This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
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Thrombosis Prevention after total hip arthroplasty a prospective randomized trial comparing a mobile compression device with low molecular weight heparin
2010Co-Authors: Clifford W Colwell, Mark I Froimson, Knute C Buehler, Michael A Mont, Douglas E Padgett, Merrill A Ritter, Robert T Trousdale, Andrew I Spitzer, Thomas K Donaldson, 勘武生 译Abstract:背景：血栓栓塞性疾病是全髋关节置换术后常见的并发症。本研究的目的在于比较新型便携式加压器与低分子量肝素在静脉血栓预防中的安全性和有效性。方法：全髋置换患者随机接受为期10d便携式加压器或者低分子量肝素预防治疗。术中开始使用加压器，并且这组患者在术后日服81mg的阿司匹林。使用肝素者，术后12-24h开始注射低分子量肝素。在10-12d后，所有患者行多普勒超声筛查双下肢小腿、大腿部深静脉血栓；有肺栓塞临床症状的患者均接受肺部螺旋CT扫描评价。记录两组出血和于预性治疗情况（即：依从性）。术后12周进行深静脉血栓和肺栓塞证据的临床评估。结果：410例患者（414髋）进行随机化分组；392例患者（395髋）进行手术安全性评估，386例（389髋）治疗结果有效。两组间的一般临床情况无差异。加压组严重出血发生率O％，低分子量肝素组6％。加压组远端和近端深静脉血栓发生率分别为3％、2％，肝素组3％、1％。肺栓塞发生率加压组1％，肝素组1％，无致命性肺栓塞。随访12周，1例加压组患者出现两项事件（深静脉血栓和肺栓塞），该患者术后第12天多普勒超声检查阴性。在静脉血栓栓塞预防上两组比较无明显差异。结论：全髋置换术后静脉血栓栓塞预防，便携式加压器与低分子量肝素比较，可明显减少严重出血。
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Thrombosis Prevention after total hip arthroplasty a prospective randomized trial comparing a mobile compression device with low molecular weight heparin
2010Co-Authors: Clifford W Colwell, Mark I Froimson, Knute C Buehler, Michael A Mont, Merrill A Ritter, Robert T Trousdale, Andrew I Spitzer, Thomas K Donaldson, Douglas E PadgettAbstract:Background: Thromboembolic disease is a common complication of total hip arthroplasty. The purpose of this study was to compare a new mobile compression device with low-molecular-weight heparin with regard to their safety and effectiveness for the Prevention of venous thromboembolic disease. Methods: Patients who had a total hip arthroplasty were randomized to receive prophylaxis with a mobile compression device or low-molecular-weight heparin for ten days. Use of the compression device began intraoperatively, and the patients in this group could receive 81 mg of aspirin daily after the surgery. The first injection of the low-molecular-weight heparin began between twelve and twenty-four hours after the surgery. After ten to twelve days, all patients underwent bilateral lower-extremity duplex ultrasonography to screen for deep venous thrombi in the calf and thigh. Any clinical symptoms of pulmonary embolism were evaluated with spiral computed tomography lung scans. Bleeding events and utilization of (i.e., compliance with) prophylactic treatment in both groups were documented. Clinical evaluation to look for evidence of deep venous thrombi and pulmonary emboli was performed at twelve weeks postoperatively. Results: Four hundred and ten patients (414 hips) were randomized; 392 of these patients (395 of the hips) were evaluable with regard to the safety of the intervention and 386 patients (389 hips) were evaluable with regard to its efficacy. Demographics were similar clinically between the groups. The rate of major bleeding events was 0% in the compression group and 6% in the low-molecular-weight heparin group. The rates of distal and proximal deep venous Thrombosis were 3% and 2%, respectively, in the compression group compared with 3% and 1% in the heparin group. The rates of pulmonary embolism were 1% in the compression group and 1% in the heparin group, and there were no fatal pulmonary emboli. Within the twelve-week follow-up period, two events (one deep venous Thrombosis and one pulmonary embolus) occurred in one patient in the compression group following negative findings on duplex ultrasonography on the twelfth postoperative day. There was no difference between the groups with regard to the prevalence of venous thromboembolism. Conclusions: When compared with low-molecular-weight heparin, use of the mobile compression device for prophylaxis against venous thromboembolic events following total hip arthroplasty resulted in a significant decrease in major bleeding events. Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.
Thomas W Wakefield - One of the best experts on this subject based on the ideXlab platform.
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endovenous laser ablation venous outcomes and thrombotic complications are independent of the presence of deep venous insufficiency
2008Co-Authors: Brian S Knipp, Susan Blackburn, Jess R Bloom, Elaine P Fellows, William Laforge, John R Pfeifer, David M Williams, Thomas W WakefieldAbstract:Objective We hypothesize that endovenous laser ablation (EVA) therapy is equally successful in improving venous insufficiency symptoms in patients with or without deep venous insufficiency (DVI). Methods From January 2005 through August 2007, EVA of the great saphenous vein (GSV) was attempted in 364 patients (460 limbs) with symptomatic GSV reflux. The GSV was successfully cannulated and obliterated in all but 17 limbs. EVA was performed alone in 308 limbs (69.5%) and with phlebectomy or perforator ligation (EVAP) in 135 limbs (30.5%). Venous clinical severity scores (VCSS) were recorded preoperatively and at 30, 90, 180, and 360 days postoperatively. Patients were classified as those with or without DVI based on duplex imaging valve closure times at the common femoral vein (CFV) and popliteal vein (PV). In a subset of 181 patients undergoing EVA therapy in the operating room, perioperative Thrombosis prophylaxis was administered based on a risk-stratification protocol. Patients were assessed with direct end points (VCSS) and indirect end points (vein occlusion rates). Results Successful performance of EVA led to complete saphenous vein ablation in 99.8% at 1 month and 95.9% at 1 year. Median VCSS preoperatively was 6 (interquartile range, 5-8), generally decreasing over all time points to 4 (interquartile range, 2-5) beyond 360 days ( P P = .019). Changes in VCSS and duration of vessel occlusion were equivalent regardless of DVI for both isolated EVA and EVAP. For EVAP, the true deep venous Thrombosis (DVT) rate was 2.2%, whereas for isolated EVA, the rate was 0% ( P = .028); the rate of saphenofemoral thrombus extension was 5.9% for EVAP vs 7.8% for isolated EVA ( P = .554). The use of risk-adjusted heparin prophylaxis in patients undergoing EVAP did not have a significant effect on thrombotic complications. There were no differences in true DVT, thrombus extension, or superficial thrombophlebitis between patients with or without DVI. Performance of concomitant phlebectomy, DVI, gender, and age had no effect on the duration of vessel occlusion. Conclusion EVA produces successful ablation and is associated with sustained improvement in VCSS. These outcomes are independent of the presence of DVI. Finally, the use of a risk-adjusted Thrombosis Prevention protocol had no effect on the rate of superficial thrombus extension from EVA or EVAP in patients undergoing general anesthesia.
Samuel Z Goldhaber - One of the best experts on this subject based on the ideXlab platform.
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intermittent pneumatic compression and deep vein Thrombosis Prevention in postoperative patients
2006Co-Authors: Jitka Urbankova, Rene Quiroz, Samuel Z GoldhaberAbstract:High incidence of venous thromboembolism (VTE) makes prophylaxis, screening and treatment extremely important. Both pharmacological and mechanical techniques can be used to reduce the risk of deep vein Thrombosis (DVT). Mechanical methods have been studied much less intensively than pharmacological options. The principal mechanical methods of prophylaxis are graduated compression stockings and intemittent pneumatic compression devices. We conducted a meta-analysis of all randomized controlled trials to determine the effectiveness of intermittent pneumatic compression (IPC) devices in the preventon of DVT in post-surgical patients. The results of this analysis indicate that IPC devices reduced the risk of DVT by 60% when compared with patients with no mechanical or pharmacological prophylaxis. Contemporary randomized trials should be undertaken to test the utility of IPC in medcal patients as well as combined pharmacological plus IPC prophylaxis in both medical patients.
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intermittent pneumatic compression and deep vein Thrombosis Prevention a meta analysis in postoperative patients
2005Co-Authors: Jitka Urbankova, Rene Quiroz, Nils Kucher, Samuel Z GoldhaberAbstract:Our objective was to overview the effectiveness of intermittent pneumatic compression (IPC) devices to prevent deep vein Thrombosis (DVT) in postoperative patients, using meta-analysis methodology.We searched the Medline, metaRegister of Controlled Trials, and Cochrane database for studies published between 1970 and October 2004. Our inclusion criteria were: 1) randomized controlled trial of IPC versus no prophylaxis, 2) at least 20 patients per group, 3) at least one diagnostic DVT imaging test in all patients, and 4) clinical follow-up for at least the duration of hospitalization. A total of 2,270 patients were in- cluded in 15 eligible studies: 1,125 and 1,145 in the IPC and no prophylaxis group, respectively. The included studies formed a total of 16 treatment groups and were conducted in orthopedic, general surgical, oncologic, neurosurgical and urologic patient populations. In comparison to no prophylaxis, IPC devices reduced the risk of DVT by 60% (relative risk 0.40, 95% CI 0.29 – 0.56; p< 0.001). Contemporary randomized trials should be undertaken to test the utility of IPC in hospitalized medical patients as well as combined pharmacological plus IPC prophylaxis in both medical and surgical patients.