Evidence map›Paper›PMID 29544550›Full record

ArticleTrials2018

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

Yaseen Arabi, Fahad Al-Hameed, Karen E A Burns, Sangeeta Mehta, Sami Alsolamy, Mohammed Almaani, Yasser Mandourah, Ghaleb A Almekhlafi, Ali Al Bshabshe, Simon Finfer and 15 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02040103 (Prophylaxis of Thromboembolism in Critically Ill Patients Using Combined Intermittent Pneumatic Compression), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02040103 nacompletednot on this map

Prophylaxis of Thromboembolism in Critically Ill Patients Using Combined Intermittent Pneumatic Compression(IPC) and Pharmacologic Prophylaxis Versus Pharmacologic Prophylaxis Alone: A Multicenter Randomized Controlled Trial

TypeinterventionalSponsorKing Abdullah International Medical Research CenterRan2014 to 2018Enrolled2,000ConditionsDeep Venous ThrombosisArmspneumatic compression
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020
    Guideline
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Yaseen ArabiKing Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia. arabi@ngha.med.sa.ORCID http://orcid.org/0000-0001-5735-6241
Fahad Al-HameedDepartment of Intensive Care, College of Medicine-Jeddah, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.
Karen E A BurnsInterdepartmental Division of Critical Care Medicine, St Michael's Hospital, Li Ka Shing Knowledge Institute, Toronto, ON, Canada.
Sangeeta MehtaInterdepartmental Division of Critical Care Medicine, Mount Sinai Hospital, Toronto, ON, Canada.
Sami AlsolamyKing Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
Mohammed AlmaaniDepartment of Pulmonary and Critical Care Medicine, King Fahad Medical City, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.
Yasser MandourahDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Ghaleb A AlmekhlafiDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Ali Al BshabsheDepartment of Critical Care Medicine, King Khalid University, Asir Central Hospital, Abha, Kingdom of Saudi Arabia.
Simon FinferIntensive Care, Royal North Shore Hospital and The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
Mohammed AlshahraniDepartment of Emergency and Critical Care, Imam Abdulrahman Bin Faisal University, Al Khobar, Kingdom of Saudi Arabia.
Imran KhalidCritical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center, Jeddah, Kingdom of Saudi Arabia.
Yatin MehtaInstitute of Critical Care and Anaesthesiology, Medanta - The Medicity, Gurgaon, Haryana, India.
Atul GaurIntensive Care Department, Gosford Hospital, Gosford, NSW, Australia.
Hassan HawaCritical Care Medicine Department, King Faisal Specialist Hospital and Research Centre, Riyadh, Kingdom of Saudi Arabia.
Hergen BuscherIntensive Care Medicine, St. Vincent's Hospital, Sydney, NSW, Australia.
Zia ArshadDepartment of Anesthesiology and Critical Care, King George's Medical University, Lucknow, India.
Hani LababidiDepartment of Pulmonary and Critical Care Medicine, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia.
Abdulsalam Al AithanIntensive Care and Pulmonary Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Al Ahsa, Kingdom of Saudi Arabia.
Jesna JoseKing Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
Sheryl Ann I AbdukahilKing Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
Lara Y AfeshKing Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
Maamoun DbsawyKing Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
Abdulaziz Al-DawoodKing Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
PREVENT trial Group

Funding

King Abdulaziz City for Science and Technology AT 65-34King Abdullah International Medical Research Center RC12/045/R
6 · The paper itself

Abstract

backgroundThe Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. METHODS/

designIn this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. DISCUSSION: Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data.

trial registrationClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

Indexed as

Data Interpretation, StatisticalIntermittent Pneumatic Compression DevicesRandomized Controlled Trials as TopicHumansMulticenter Studies as TopicTreatment OutcomeVenous ThromboembolismAdjunct mechanical and pharmacologic DVT prophylaxisCritically-ill patientsDeep vein thrombosisIntermittent pneumatic compressionPulmonary embolism

Identifiers

PMID29544550
PMCPMC5856363

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.