✓ Translated by DotMD AI Clinical Council Source: Research and practice in thrombosis and haemostasis • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #42656610 ↗

Phase III Randomized Trial: High-dose four-factor prothrombin complex concentrate for vitamin K antagonist reversal before urgent surgery: subanalysis of the LEX-209 randomized, active-controlled trial (N = 15)

Original Paper Title: “High-dose four-factor prothrombin complex concentrate for vitamin K antagonist reversal before urgent surgery: subanalysis of the LEX-209 randomized, active-controlled trial”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 15
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • In this small sample, 4F-PCC, at the maximum permitted dose, was effective for VKA reversal in patients requiring urgent surgery, with no adverse safety signal observed.
  • Study Design & Sample: Phase III Randomized Trial published in Research and practice in thrombosis and haemostasis (N = 15 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Research and practice in thrombosis and haemostasis (2026), this phase iii randomized trial evaluating 15 human participants investigated: Four-factor prothrombin complex concentrates (4F-PCCs) reverse vitamin K antagonist (VKA)-induced acquired coagulation factor deficiency. Key clinical takeaway: In this small sample, 4F-PCC, at the maximum permitted dose, was effective for VKA reversal in patients requiring urgent surgery, with no adverse safety signal observed.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Research and practice in thrombosis and haemostasis, 2026-07-15; N = 15; Rigor 82/100): In this small sample, 4F-PCC, at the maximum permitted dose, was effective for VKA reversal in patients requiring urgent surgery, with no adverse safety signal observed.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: vitamin-mineral-supplement → Rx: iron-folic-acid-vitamin-mineral-supplement → Condition: surgery → Condition: vitamin-k →
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