A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability
Model scores of the 29,894 trials active now.
Model score 7% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 7% of the time (56 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.
How it ended
Completed on 2017-12-31, after 2013-05-31 start.
The score above never used this outcome: 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.
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 2017-12-31. 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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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: the investigatorsspinalnonimprovehypertension
Phrases that lowered it: diabetesmellitus45 yearshypotensionmedical -
Minimum age: 21 (lowers risk) · Who can join
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Accepts healthy volunteers: No (raises risk) · Who can join
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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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Phase: 2/3 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 11.7% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 2 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 7050 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 72.9% (raises risk) · Drug's FDA history
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 45 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 29852 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7050 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- ephedrine, phenylephrine
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
- Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section NCT04025918 · started 2011 · scored riskier than 5% of active trials completed
- Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery NCT05335954 · started 2022 · scored riskier than 58% of active trials completed
- Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension NCT04789005 · started 2019 · scored riskier than 7% of active trials completed
- Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery NCT07034911 · started 2024 · scored riskier than 5% of active trials completed
- Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section NCT04140058 · started 2016 · scored riskier than 7% 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.