The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 4% 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 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 2012-09-30, after 2012-01-31 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 2012-09-30. 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
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 30 (lowers risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Blinding: single (lowers risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Responsible party: principal investigator (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: bypasscardiopulmonarytimesurgerycoronary
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacymonths before -
Drug's FAERS reports with a death: 33.3% (raises risk) · Drug's FDA history
-
Maximum age: 70 (lowers risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
-
Number of arms: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 30 (typical: 18)
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (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
- 6 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 33.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- hydroxyethyl starch
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
- Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : Pilot Study in Adult Elective Conventional Cardiac Surgery NCT02906514 · started 2016 · scored riskier than 36% of active trials completed
- Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery NCT05223361 · started 2016 · scored riskier than 30% of active trials completed
- The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols NCT01511120 · started 2011 · scored riskier than 80% of active trials completed
- A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume NCT00816023 · started 2009 · scored riskier than 60% of active trials completed
- Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery NCT01519245 · started 2011 · scored riskier than 22% 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.