Evidence map›Paper›PMID 40525206›Full record

ArticleJournal of the American College of Emergency Physicians open2025

Four-Factor Prothrombin Complex Concentrate vs Plasma in Patients on Vitamin K Antagonists With Gastrointestinal Bleeding or Needing a Gastrointestinal Procedure: A Retrospective Analysis of 2 Randomized Controlled Trials.

Majed A Refaai, Joshua N Goldstein

Abstract read
In one paragraph

Article in Journal of the American College of Emergency Physicians open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. 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

2 authors.

Majed A RefaaiSchool of Medicine and Dentistry, University of Rochester, Rochester, New York, USA.
Joshua N GoldsteinDepartment of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: To examine the efficacy of 4-factor prothrombin complex concentrate (4F-PCC) compared with plasma in vitamin K antagonist (VKA)-treated patients with gastrointestinal (GI) bleeding or requiring a GI surgical/invasive procedure. Methods: A retrospective analysis was conducted on a subset of data from 2 prospective phase 3b randomized controlled trials of 4F-PCC or plasma for VKA reversal. Data from patients receiving VKA who experienced acute major GI bleeding or needed a GI surgical/invasive procedure within 24 hours were included in the analysis. Hemostatic efficacy, international normalized ratio (INR), and vitamin K-dependent coagulation factor (VKDF) restoration were analyzed. Results: In total, 171 patients were included in the analysis. Overall, hemostatic efficacy was rated excellent and good in 68 of 83 (81.9%) and 66 of 88 (75.0%) patients in the 4F-PCC and plasma treatment groups, respectively (odds ratio [OR], 1.52; 95% CI, 0.72-3.20). At 0.5 hours after infusion, 68.2% of patients treated with 4F-PCC achieved an INR of ≤1.3 compared with 0.0% of patients treated with plasma (68% difference; 95% CI, 57-79). Time to INR restoration from the start of infusion was significantly shorter for 4F-PCC than plasma (45 vs 1326 minutes, respectively; OR, 0.10; 95% CI, 0.07-0.14). All VKDF levels were significantly higher in the 4F-PCC group vs the plasma group within 3 hours from the start of infusion (all Conclusion: 4F-PCC was associated with a nearly immediate decrease in INR and rapid VKDF restoration compared with plasma in patients experiencing acute major GI bleeding or in need of GI surgery/invasive procedure. Yet, hemostatic efficacy was similar between the 2 groups, and therefore, larger studies might be needed to better understand patient outcomes.

Indexed as

4-factor prothrombin complex concentrategastrointestinal bleedinggastrointestinal surgeryplasmavitamin K antagonist reversal

Identifiers

PMID40525206
PMCPMC12169307

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