Evidence map›Paper›PMID 34024021›Full record

SynthesisJournal of thrombosis and thrombolysis2021

Prothrombin complex concentrate in major bleeding associated with DOACs; an updated systematic review and meta-analysis.

Ioannis Milioglou, Ioannis Farmakis, Mandy Neudeker, Zeeshan Hussain, Avirup Guha, George Giannakoulas, Vassiliki Kotoula, Maria Papaioannou

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Journal of thrombosis and thrombolysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Reversal of oral anticoagulation in emergency conditions.Blood transfusion = Trasfusione del sangue · 2025
    Article
  4. Article
  5. Review
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

8 authors at 3 institutions in 2 countries.

Ioannis MilioglouCase Western Reserve University, Cleveland, OH, USA. ioannismilioglou@gmail.com.
Ioannis FarmakisDepartment of Cardiology, AHEPA University Hospital, Thessaloniki, Greece.
Mandy NeudekerUniversity Hospitals Cleveland Medical Center, Harrington Heart and Vascular Institute, Cleveland, OH, USA.
Zeeshan HussainCase Western Reserve University, Cleveland, OH, USA.
Avirup GuhaCase Western Reserve University, Cleveland, OH, USA.
George GiannakoulasDepartment of Cardiology, AHEPA University Hospital, Thessaloniki, Greece.
Vassiliki KotoulaHematology Unit, 1st Department of Internal Medicine, AHEPA University Hospital, Thessaloniki, Greece.
Maria PapaioannouPathology Department, AHEPA University Hospital, Thessaloniki, Greece.
AHEPA University Hospital · GRUniversity Hospitals of Cleveland · USCase Western Reserve University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFour-factor prothrombin complex concentrate (PCC) is frequently used as a reversal agent for major bleeding in patients on factor Xa inhibitors. Piran et al. reviewed its safety and efficacy for the first time in 2018. However, more studies have been published on the matter since then. The aim of this study is to investigate the efficacy and safety of this use and update this review.

methodsWe systematically searched in Medline, Scopus, and the Cochrane Library from 1/1/2018 to 6/19/2020. A random effects model meta-analysis of proportions was used to study the efficacy of PCC on major bleeding control, mortality and thrombosis incidence.

results33 studies (n = 2568 patients), with the majority of studies being uncontrolled retrospective cohort studies, were included; atrial fibrillation was the main factor Xa inhibitors indication and approximately 62% of patients presented with intracranial hemorrhage. We estimated the pooled proportion outcomes for hemostasis (80%, CI 0.75-0.84), mortality (15%, CI 0.11-0.19) and thromboembolic adverse events (3%, CI 0.02-0.05). High versus low dose PCC did not affect hemostasis or thrombosis. Patients with ICH had higher mortality rates (22%, CI 0.13-0.32). Heterogeneity was significant (Ι

conclusionOur study demonstrates the efficacy and safety of the off label use of 4F PCC in major bleeding associated with factor Xa inhibitors. Our data require further validation with future randomized clinical trials.

Indexed as

HemorrhageThromboembolismAnticoagulantsBlood Coagulation FactorsFactor IXFactor Xa InhibitorsHumansRetrospective StudiesAnticoagulantsBlood Coagulation FactorsFactor IXFactor Xa Inhibitorsprothrombin complex concentratesAntidoteBleedingDirect oral anticoagulantsFactor xa inhibitorsReversal

Identifiers

PMID34024021
OpenAlexW3165794421

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.