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Surveillance or no surveillance for deep venous thrombosis and outcomes of critically ill patients: A study protocol and statistical analysis plan.

ABSTRACT: OBJECTIVE:Surveillance ultrasounds in critically ill patients detect many deep venous thrombi (DVTs) that would otherwise go unnoticed. However, the impact of surveillance for DVT on mortality among critically ill patients remains unclear. DESIGN:We are conducting a multicenter, multinational randomized controlled trial that examines the effectiveness of adjunct intermittent pneumatic compression use with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on the incidence of proximal lower extremity DVT in critically ill patients (the PREVENT trial). Enrolled patients undergo twice weekly surveillance ultrasounds of the lower extremities as part of the study procedures. We plan to compare enrolled patients who have surveillance ultrasounds to patients who meet the eligibility criteria but are not enrolled (eligible non-enrolled patients) and only who will have ultrasounds performed at the clinical team's discretion. We hypothesize that twice-weekly ultrasound surveillance for DVT in critically ill patients who are receiving thromboprophylaxis will have more DVTs detected, and consequently, fewer pulmonary emboli and lower all-cause 90-day mortality. DISCUSSION:We developed a detailed a priori plan to guide the analysis of the proposed study and enhance the validity of its results.

SUBMITTER: Arabi YM

PROVIDER: S-EPMC6133421 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Surveillance or no surveillance for deep venous thrombosis and outcomes of critically ill patients: A study protocol and statistical analysis plan.

Arabi Yaseen M YM Burns Karen E A KEA Al-Hameed Fahad F Alsolamy Sami S Almaani Mohammed M Mandourah Yasser Y Almekhlafi Ghaleb A GA Al Bshabshe Ali A Alshahrani Mohammed M Khalid Imran I Hawa Hassan H Arshad Zia Z Lababidi Hani H Al Aithan Abdulsalam A Jose Jesna J Abdukahil Sheryl Ann I SAI Afesh Lara Y LY Al-Dawood Abdulaziz A

Medicine 20180901 36

<h4>Objective</h4>Surveillance ultrasounds in critically ill patients detect many deep venous thrombi (DVTs) that would otherwise go unnoticed. However, the impact of surveillance for DVT on mortality among critically ill patients remains unclear.<h4>Design</h4>We are conducting a multicenter, multinational randomized controlled trial that examines the effectiveness of adjunct intermittent pneumatic compression use with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxi ...[more]

PMID: 30200162

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Project description:Introduction: Atherosclerosis and pulmonary embolism (PE) affect cardiovascular mortality substantially. We aimed to investigate the impact of atherosclerosis on the outcomes of patients with deep venous thrombosis (DVT) and to identify the differences in DVT patients with and without PE. Methods: Patients with DVT with and without symptomatic atherosclerosis (defined as coronary artery disease, myocardial infarction and/or peripheral artery disease) as well as with and without PE under oral anticoagulation were enrolled during January 2011−April 2013 and compared. The impact of symptomatic atherosclerosis on several outcomes was analyzed. Results: Overall, 509 DVT patients (70.0 [56.0−77.0] years, 51.9% females) were included in this study. Among them, 179 (36.3%) had symptomatic atherosclerosis and 204 (40.1%) a concomitant PE. DVT patients with symptomatic atherosclerosis were older (74.0 [IQR 65.0−80.0] vs. 63.0 [48.0−75.0] years, p < 0.0001), more often male (56.4% vs. 43.9%, p = 0.0087) and had a higher prevalence of classical CVRF and a higher Charlson comorbidity index (7.00 [5.00−8.00] vs. 4.00 [2.00−6.00], p < 0.001). Symptomatic atherosclerosis was associated with increased mortality (HR 1.98 [95%CI 1.12−3.49], p = 0.018) and hospitalizations (HR 1.64 [95%CI 1.21−2.21], p = 0.0012) and primary long-term outcome (HR 1.99 [95%CI 1.31−3.04], p = 0.0013) during the 2 years follow-up-period in DVT patients. DVT patients without PE had diabetes mellitus (28.2% vs. 16.3%, p < 0.01) and symptomatic atherosclerosis (42.9% vs. 26.4%, p < 0.001) more often compared to DVT patients with PE, and symptomatic atherosclerosis was associated with isolated DVT (without PE) (OR 2.01 [95%CI 1.28−3.16], p < 0.01). Conclusions: Atherosclerosis was associated with isolated DVT (without PE) and increased mortality in DVT patients under oral anticoagulation. The profile of CVRF and comorbidities differed between DVT patients with and without a concomitant PE. In the case of DVT or PE, patients should be screened for concomitant atherosclerotic disease. Clinical Trial Registration: at clinicaltrials with Unique identifier NCT01809015.

Project description:BackgroundStudies have shown routine ultrasound surveillance (RUSS) will facilitate deep vein thrombosis (DVT) detection in patients with trauma and reduce the subsequent incidence of pulmonary embolism (PE); however, the findings were inconsistent. In adults with trauma at a high risk of venous thromboembolism, this systematic review and meta-analysis compared RUSS outcomes with those of "no RUSS."MethodsThree databases were screened for relevant articles from inception to October 18, 2021. Randomized controlled trials (RCTs) and observational studies comparing RUSS with no RUSS were included. We used relative risks (RRs), odds ratios (ORs), and mean differences to pool effect estimates for dichotomous and continuous outcomes. The cochrane risk of bias or the risk of bias in non-randomized studies of interventions were used to assess bias risk. The grading of recommendations, assessment, development, and evaluation framework assessed the certainty of the evidence.FindingsOut of 1685 articles, 5 met the inclusion criteria (RCT: 1; observational studies: 4). Observational studies suggested RUSS is associated with higher odds of DVT detection (OR, 4.87; 95% confidence interval [CI], 3.13-7.57; very low certainty). Whereas higher risks of DVT were associated with RUSS in the RCT (distal DVT: RR, 15.48; 95% CI, 7.62-31.48; low certainty, and proximal DVT: RR, 2.37; 95% CI, 1.04-5.39; very low certainty). Reduced odds of PE risk were observed with the RUSS (OR, 0.47; 95% CI, 0.24-0.91; very low certainty). Observational studies indicated that RUSS had an uncertain effect on mortality (OR, 0.46; 95% CI, 0.06-3.49). In the RCT, times to proximal and distal DVT diagnoses were shorter with RUSS (proximal DVT, mean difference 2.25 days shorter [95% CI, 5.74-1.24]; distal DVT, mean differences 1.56 days shorter [95% CI, 4.22-1.12]; very low certainty for both). Increasing bleeding risk was not linked to the RUSS group (RR, 1.24; 95% CI, 0.31-4.92).InterpretationThe RUSS efficacy in adults with trauma at high risk for venous thromboembolism showed that it increases DVT detection, decreases PE incidence, and shortens the time to DVT diagnosis, with an uncertain impact on mortality. The evidence is low or very low in certainty because of bias, inconsistency, imprecision, and indirectness.

Dataset Information

Surveillance or no surveillance for deep venous thrombosis and outcomes of critically ill patients: A study protocol and statistical analysis plan.

Publications

Surveillance or no surveillance for deep venous thrombosis and outcomes of critically ill patients: A study protocol and statistical analysis plan.

Similar Datasets

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