PeriOperative ISchemic Evaluation-3 Trial
Model scores of the 29,894 trials active now.
Model score 12% 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 20% of the time (381 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-02-03, after 2018-06-27 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-02-03. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: myocardialinfarctionpatientsheart failurecongestive heart
Phrases that lowered it: historysmoking45 yearsconsumptiontaking -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: factorial (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 45 (lowers risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 95.6% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 7.4% (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 14 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports with a death: 20.9% (lowers risk) · Drug's FDA history
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Keywords listed: 6 (lowers 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.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 45 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 27 (typical: 32)
- Sponsor's past termination rate
- 7.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3309 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 693 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- tranexamic acid
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study NCT02546648 · started 2015 · scored riskier than 31% of active trials completed
- Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass NCT02037555 · started 2014 · scored riskier than 49% of active trials completed
- DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery NCT03954314 · started 2019 · scored riskier than 42% of active trials terminated
- PeriOperative ISchemic Evaluation-2 Trial NCT01082874 · started 2010 · scored riskier than 33% of active trials completed
- Topical Tranexamic Acid (TXA) in Hip Fractures NCT02993341 · started 2016 · scored riskier than 25% 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.