Dataset Information

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial.

ABSTRACT: Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE.The PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %.The first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018.Clinicaltrials.gov: NCT02040103 (registered on 3 November 2013). Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).

SUBMITTER: Arabi YM

PROVIDER: S-EPMC4972959 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial.

Arabi Yaseen M YM Alsolamy Sami S Al-Dawood Abdulaziz A Al-Omari Awad A Al-Hameed Fahad F Burns Karen E A KE Almaani Mohammed M Lababidi Hani H Al Bshabshe Ali A Mehta Sangeeta S Al-Aithan Abdulsalam M AM Mandourah Yasser Y Almekhlafi Ghaleb G Finfer Simon S Abdukahil Sheryl Ann I SA Afesh Lara Y LY Dbsawy Maamoun M Sadat Musharaf M

Trials 20160803 1

<h4>Background</h4>Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis c ...[more]

PMID: 27488380

Similar Datasets

Project description:Venous thromboembolic events (VTE) are frequent complications in hospitalized patients and a leading cause of preventable death in hospital. Pharmacologic prophylaxis is a standard of care to prevent VTE in patients at risk, the additional value of intermittent pneumatic compression (IPC) is uncertain. We aimed to evaluate the efficacy of adding IPC to pharmacologic prophylaxis to prevent VTE in hospitalized adults.Data sourcesWe searched the Cochrane Central Register of Controlled Trials, Embase, MEDLINE, Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov, and the International Clinical Trials Registry Platform from inception to July 2022.Study selectionWe included randomized controlled trials comparing the use of IPC in addition to pharmacological thromboprophylaxis to pharmacological thromboprophylaxis alone in hospitalized adults.Data extractionMeta-analyses were performed to calculate risk ratio (RR) of VTE, deep venous thrombosis (DVT), and pulmonary embolism (PE). We assessed the risk of bias using the Cochrane Risk of Bias Tool for Randomized Trials, Version 2 and the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach.Data synthesisWe included 17 trials enrolling 8,796 participants. The IPC was mostly applied up to the thigh and pharmacological thromboprophylaxis was primarily low-molecular-weight heparin. Adjunctive IPC was associated with a decreased risk of VTE (15 trials, RR = 0.53; 95% CI [0.35-0.81]) and DVT (14 trials, RR = 0.52; 95% CI [0.33-0.81]) but not PE (seven trials, RR = 0.73; 95% CI [0.32-1.68]). The quality of evidence was graded low, downgraded by risk of bias and inconsistency. Moderate and very low-quality evidence, respectively, suggests that adjunctive IPC is unlikely to change the risk of all-cause mortality or adverse events. Subgroup analyses indicate a more evident apparent benefit in industry-funded trials.ConclusionsResults indicate low-quality evidence underpinning the additional use of IPC to pharmacological thromboprophylaxis for prevention of VTE and DVT. Further large high-quality randomized trials are warranted to support its use and to identify patient subgroups for whom it could be beneficial.

Project description:IntroductionPatients with an intracerebral haemorrhage are at increased risk of venous thromboembolism. Pharmacotherapy and pneumatic compression devices are capable of preventing venous thromboembolism, however both interventions have limitations. There are no head-to-head comparisons between these two interventions. To address this knowledge gap, we plan to perform a systematic review and network meta-analysis to examine the comparative effectiveness of pharmacological prophylaxis and mechanical compression devices in the context of intracerebral haemorrhage.Methods and analysisMEDLINE, PUBMED, EMBASE, CENTRAL, ClinicalTrials.gov and the Internet Stroke Trials Registry will be searched with assistance from an experienced information specialist. Eligible studies will include those that have enrolled adults presenting with spontaneous intracerebral haemorrhage and compared one or more of the respective interventions against each other and/or a control. Primary outcomes to be assessed are occurrence of new venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) and haematoma expansion, defined as a significant enlargement of baseline haemorrhage or new haemorrhage occurrence. Both randomised and non-randomised comparative studies will be included. Data on participant characteristics, study design, intervention details and outcomes will be extracted. Study quality will be assessed using the Cochrane Risk of Bias Tool and the Robins-I tool. Bayesian network meta-analyses will be performed to compare interventions based on all available direct and indirect evidence. If the transitivity assumption for network meta-analysis cannot be met, we will perform a qualitative assessment.Ethics and disseminationFormal ethics is not required as primary data will not be collected. The findings of this study will be disseminated through conference presentations, and peer-reviewed publications. In an area of clinical practice where equipoise exists, the findings of this study may assist in determining which treatment intervention is most effective in venous thromboembolism prevention.Prospero registration numberCRD42018090960.

Dataset Information

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial.

Publications

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets