Effects of Oxygen Treatment on Mechanisms Involved in Ischemia-reperfusion Injury: A Pilot Study in Healthy Volunteers

NCT02286544 on ClinicalTrials.gov Phase 1 Karolinska Institutet (academic or other) Started 2014-10-31 Completed

Riskier than 6% of active trials

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (141 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 2015-12-31, after 2014-10-31 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 2015-12-31. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 1.6% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 78 (lowers risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: injurymyocardialacuteinfarctioncoronary
Phrases that lowered it: effecthealthyvolunteerstrialir
Sponsor type: academic or other (raises risk) · Sponsor's track record
Responsible party: principal investigator (lowers risk) · Design
Blinding: single (lowers risk) · Design
Drug's FAERS reports with a death: 8.2% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: 71.0% (lowers risk) · Drug's FDA history
Collaborators: 1 (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Sponsor's past trials: 122 (lowers risk) · Sponsor's track record
Disease area, psychiatry: No (lowers 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: 1 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: single (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 14 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 40 (typical: 71)
Sex: male (typical: all)
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 122 (typical: 32)
Sponsor's past termination rate: 1.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 78 (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: 125564 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 22523 (typical: 412.5)
Drug's FAERS reports marked serious: 71.0% (typical: 85.6%)
Drug's FAERS reports with a death: 8.2% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular
Drugs matched to FDA substances: atorvastatin

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

Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction by Biomarkers NCT02290080 · started 2014 · scored riskier than 27% of active trials completed
An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction NCT01787110 · started 2013 · scored riskier than 26% of active trials completed
Effects of Oxygen Status on Endotoxemia Induced Inflammation and Hypoxia Inducible Factor-1α NCT01978158 · started 2013 · scored riskier than 5% of active trials completed
Intracoronary Injection of Epo After Myocardial Infarct Intra-CO-EpoMI NCT01043991 · started 2008 · scored riskier than 86% of active trials completed
Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief NCT01413841 · started 2011 · scored riskier than 23% 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.