PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 11% of the time (234 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-09-03. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjecttraumariskneurologicalas judged
  Phrases that lowered it: open labelanticlinical trialbleedingtreatment
• Sponsor's past termination rate: 22.7% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Has a data monitoring committee: not given (lowers risk) · Design
• Phase: 3 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 19 (lowers risk) · Sponsor's track record
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Number of arms: 2 (raises risk) · Design
• Blinding: none (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure NCT00803101 · started 2009 · scored riskier than 54% of active trials completed
• Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist NCT02866838 · started 2016 · scored riskier than 92% of active trials completed
• Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects NCT02281201 · started 2014 · scored riskier than 19% of active trials completed
• Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy NCT00708435 · started 2008 · scored riskier than 46% of active trials completed
• Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. NCT02740335 · started 2017 · scored riskier than 85% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.