Trial of PCC Versus FFP in Patients Undergoing Heart Surgery

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 13% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (107 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 2020-01-29. 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.

• Primary purpose: other (lowers risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: determinehoursheartcardiac surgerycontrolled
  Phrases that lowered it: trialpatientsand safetyefficacy andplasma
• Drug's FAERS reports with a death: 27.8% (raises risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Maximum age: not given (raises risk) · Who can join
• Number of arms: 2 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
• Collaborators: 1 (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.

• 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
• Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery NCT01475669 · started 2012 · scored riskier than 61% 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
• 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
• RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery NCT01283321 · started 2011 · scored riskier than 76% of active trials terminated

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.