Evidence map›Paper›PMID 34236768›Full record

Trial reportJournal of thrombosis and haemostasis : JTH2021

Standard prophylactic versus intermediate dose enoxaparin in adults with severe COVID-19: A multi-center, open-label, randomized controlled trial.

Usha S Perepu, Isaac Chambers, Abdul Wahab, Patrick Ten Eyck, Chaorong Wu, Sanjana Dayal, Grerk Sutamtewagul, Steven R Bailey, Lori J Rosenstein, Steven R Lentz

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of thrombosis and haemostasis : JTH, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05334615 (Cellular Effects of SARS-CoV-2 in Mediating Thrombotic Susceptibility), which is not on this map. Cited by 87 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 16 pooled it
10.2field-weighted citation impact, top 1% of its field
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.

NCT05334615 recruitingnot on this mapstarted 2022, after this paper: background citation

Cellular Effects of SARS-CoV-2 in Mediating Thrombotic Susceptibility

TypeobservationalSponsorUniversity of IowaRan2022 to 2025Enrolled180ConditionsCOVID-19
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 16 syntheses or guidelines pooled it, 168 citations in OpenAlex.

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  11. Anticoagulants for people hospitalised with COVID-19: a rapid reviewThe Cochrane database of systematic reviews · 2022
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  14. Use of anticoagulants in patients with COVID-19: a living systematic review and meta-analysis.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2022
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  15. Risk Factors for Venous Thromboembolism in Severe COVID-19: A Study-Level Meta-Analysis of 21 Studies.International journal of environmental research and public health · 2021
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27 more citing papers are in PubMed but not listed here.

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

10 authors at 3 institutions in 1 country.

Usha S PerepuDepartment of Internal Medicine, University of Iowa, Iowa City, Iowa, USA.
Isaac ChambersDepartment of Internal Medicine, University of Iowa, Iowa City, Iowa, USA.
Abdul WahabDepartment of Internal Medicine, University of Iowa, Iowa City, Iowa, USA.
Patrick Ten EyckInstitute for Clinical and Translational Science, University of Iowa, Iowa City, Iowa, USA.
Chaorong WuInstitute for Clinical and Translational Science, University of Iowa, Iowa City, Iowa, USA.
Sanjana DayalDepartment of Internal Medicine, University of Iowa, Iowa City, Iowa, USA.ORCID 0000-0001-6156-2996
Grerk SutamtewagulDepartment of Internal Medicine, University of Iowa, Iowa City, Iowa, USA.
Steven R BaileyDepartment of Internal Medicine, LSU Health Shreveport, Shreveport, Louisiana, USA.
Lori J RosensteinGunderson Health System, La Crosse, Wisconsin, USA.
Steven R LentzDepartment of Internal Medicine, University of Iowa, Iowa City, Iowa, USA.ORCID 0000-0002-8885-4718
University of Iowa · USGundersen Health System · USLouisiana State University Health Sciences Center Shreveport · US

Funding

The University of Iowa Clinical and Translational Science AwardUL1TR002537 · NCATS · UNIVERSITY OF IOWA · PI HANSEN, MARLAN R, WINOKUR, PATRICIA · 2018 to 2022
$20.0M
NCATS NIH HHS UL1 TR002537
6 · The paper itself

Abstract

backgroundCoronavirus disease 2019 (COVID-19) is associated with coagulopathy but the optimal prophylactic anticoagulation therapy remains uncertain and may depend on COVID-19 severity.

objectiveTo compare outcomes in hospitalized adults with severe COVID-19 treated with standard prophylactic versus intermediate dose enoxaparin.

methodsWe conducted a multi-center, open-label, randomized controlled trial comparing standard prophylactic dose versus intermediate dose enoxaparin in adults who were hospitalized with COVID-19 and admitted to an intensive care unit (ICU) and/or had laboratory evidence of coagulopathy. Patients were randomly assigned in a 1:1 ratio to receive standard prophylactic dose enoxaparin or intermediate weight-adjusted dose enoxaparin. The primary outcome was all-cause mortality at 30 days. Secondary outcomes included arterial or venous thromboembolism and major bleeding.

resultsA total of 176 patients (99 males and 77 females) underwent randomization. In the intention-to-treat population, all-cause mortality at 30 days was 15% for intermediate dose enoxaparin and 21% for standard prophylactic dose enoxaparin (odds ratio, 0.66; 95% confidence interval, 0.30-1.45; P = .31 by Chi-square test). Unadjusted Cox proportional hazards modeling demonstrated no significant difference in mortality between intermediate and standard dose enoxaparin (hazard ratio, 0.67; 95% confidence interval, 0.33-1.37; P = .28). Arterial or venous thrombosis occurred in 13% of patients assigned to intermediate dose enoxaparin and 9% of patients assigned to standard dose enoxaparin. Major bleeding occurred in 2% of patients in each arm.

conclusionIn hospitalized adults with severe COVID-19, standard prophylactic dose and intermediate dose enoxaparin did not differ significantly in preventing death or thrombosis at 30 days.

Indexed as

COVID-19ThrombosisAdultAnticoagulantsEnoxaparinFemaleHumansMaleSARS-CoV-2AnticoagulantsEnoxaparinanticoagulantblood coagulationCOVID-19 diseaseenoxaparinthrombosis

Identifiers

PMID34236768
PMCPMC8420176
OpenAlexW3180828297

What OpenQuestion holds

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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.