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.

Model scores of the 29,894 trials active now.

Model score 24% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (139 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-02-23. 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: hoursenrollmentstatusinjuryprior
  Phrases that lowered it: the efficacyand safetyefficacy andsafety ofthe study
• Sponsor's past termination rate: 18.8% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Drug's FAERS reports with a death: 36.4% (raises risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 90.9% (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 2 (raises risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Drug's FAERS reports before start: 11 (lowers risk) · Drug's FDA history
• Collaborators: 0 (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.

• Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures NCT00618098 · started 2008 · scored riskier than 93% of active trials completed
• 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
• Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor NCT04867837 · started 2021 · scored riskier than 47% of active trials terminated
• Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery NCT04233073 · started 2021 · scored riskier than 87% of active trials terminated
• Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery NCT05523297 · started 2022 · scored riskier than 35% 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.