Autologous Fibrin Glues for Fistulas Closure
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (340 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 2012-01-31, after 2008-01-31 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 2012-01-31. 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: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports with a death: 22.5% (raises risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: adjuvantdiseasepatientfailuresetting
Phrases that lowered it: efficacy andand safetysafety ofthe efficacyinvestigate the -
Drug's FAERS reports marked serious: 90.3% (raises risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- 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
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 493 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 109 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive
- Drugs matched to FDA substances
- lactitol, octreotide
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
- Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis NCT05264467 · started 2018 · scored riskier than 23% of active trials completed
- Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery NCT01662856 · started 2012 · scored riskier than 14% of active trials completed
- Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing NCT06632418 · started 2024 · scored riskier than 43% of active trials completed
- Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries NCT01754480 · started 2013 · scored riskier than 15% of active trials completed
- Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis NCT00684047 · started 2008 · scored riskier than 15% 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.