Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study

NCT01576679 on ClinicalTrials.gov Phase 3 The Hospital for Sick Children (academic or other) Started 2012-03-31 Terminated

Riskier than 58% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 16% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (313 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

Terminated on 2017-06-30, after 2012-03-31 start.

Reason given by the sponsor: “enrollment”

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 2017-06-30. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: tumorenrollmentthe patientintra abdominalabscess
Phrases that lowered it: the efficacyblinddrugparticipatethe study
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 33.1% (raises risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Design: parallel (raises risk) · Design
Sponsor's past termination rate: 7.4% (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 43 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 96.4% (raises risk) · Drug's FDA history
Minimum age: not given (raises risk) · Who can join
Maximum age: 18 (raises risk) · Who can join
Responsible party: principal investigator (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Collaborators: 0 (raises risk) · Design
Sponsor's past trials: 81 (lowers risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 135 (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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: 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: 5 (typical: 1)

Who can join

Minimum age: not given (typical: 18)
Maximum age: 18 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 81 (typical: 32)
Sponsor's past termination rate: 7.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 43 (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: 275 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 135 (typical: 412.5)
Drug's FAERS reports marked serious: 96.4% (typical: 85.6%)
Drug's FAERS reports with a death: 33.1% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: alteplase, plasminogen

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

Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial) NCT01717742 · started 2012 · scored riskier than 51% of active trials completed
Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood NCT00798278 · started 2008 · scored riskier than 14% of active trials completed
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis NCT02664220 · started 2016 · scored riskier than 65% of active trials completed
Antibiotic Irrigations for Intra-Abdominal Drains NCT03476941 · started 2019 · scored riskier than 36% of active trials terminated
Piperacillin/Tazobactam Versus ceftriAxone and Metronidazole for Children With Perforated Appendicitis (ALPACA) NCT05943223 · started 2024 · scored riskier than 14% 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.