Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
Model scores of the 29,894 trials active now.
Model score 14% 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 10% of the time (1,463 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 2012-03-31 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: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.8% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 62 (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Sponsor's past trials: 204 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Collaborators: 1 (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: randomizationtreatment ofsecondarysubjectshours
Phrases that lowered it: participantbleedingtrialsurgeryand safety -
Maximum age: not given (raises risk) · Who can join
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
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 204 (typical: 32)
- Sponsor's past termination rate
- 11.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 62 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- none matched
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
- TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery NCT01192022 · started 2010 · scored riskier than 20% of active trials completed
- Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery NCT02014402 · started 2013 · scored riskier than 24% of active trials completed
- Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis NCT04083807 · started 2019 · scored riskier than 22% of active trials completed
- A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery NCT02284256 · started 2014 · scored riskier than 45% of active trials completed
- The Fibrin Patch Soft Tissue Study NCT00658723 · started 2008 · scored riskier than 38% 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.