Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery
Model scores of the 29,894 trials active now.
Model score 14% 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 15% of the time (446 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-06-30, after 2021-02-01 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 2022-06-30. 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: ironacutecardiactermmechanical
Phrases that lowered it: participants28adultableextract -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 6.5% (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Number of arms: 5 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 67 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Collaborators: 2 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 64.9% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 277 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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
- 2
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 277 (typical: 32)
- Sponsor's past termination rate
- 6.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 67 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 90771 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 10251 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- aminolevulinic acid, ferrous
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
- 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
- Heme Arginate in Cardiac Surgery Patients NCT02142699 · started 2014 · scored riskier than 28% 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
- Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery NCT01530399 · started 2012 · scored riskier than 78% of active trials terminated
- Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery NCT00953212 · started 2009 · scored riskier than 42% 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.