Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 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 2013-11-30, after 2008-08-20 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 2013-11-30. 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
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Sponsor's past termination rate: 30% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: majorbleedingplacebovascularblood
Phrases that lowered it: with hepaticconsent formsevere renalthe efficacysurvival -
Accepts healthy volunteers: No (raises risk) · Who can join
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Primary purpose: prevention (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 26.8% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 10 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 97.6% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports before start: 209 (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Blinding: double (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- academic or other
- Sponsor's past trials
- 10 (typical: 32)
- Sponsor's past termination rate
- 30% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 20 (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
- 209 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 68 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- tranexamic acid
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
- Tranexamic Acid Versus Placebo for Blood to Reduce Perioperative Bleeding Post-liver Resection NCT01651182 · started 2014 · scored riskier than 29% of active trials completed
- 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 Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis NCT04459871 · started 2019 · scored riskier than 37% of active trials completed
- Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA NCT01881568 · started 2013 · scored riskier than 23% of active trials completed
- Tranexamic Acid for Unilateral Total Knee Arthroplasty NCT01594671 · started 2012 · scored riskier than 65% 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.