HiFIT Study : Hip Fracture: Iron and Tranexamic Acid
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 11% of the time (234 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-09-16, after 2017-03-31 start.
Reason given by the sponsor: “safety”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2021-09-16. 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: fracturebonehipanemiaintravenous
Phrases that lowered it: bloodweekwaymetabolismcounter -
Sponsor's past termination rate: 18.6% (raises risk) · Sponsor's track record
-
Design: factorial (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Blinding: triple (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports marked serious: 95.4% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 31 (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports with a death: 20.7% (lowers risk) · Drug's FDA history
-
Number of arms: 4 (lowers risk) · Design
-
Sponsor type: government (raises risk) · Sponsor's track record
-
Drug's FAERS reports before start: 2485 (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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (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
- government (typical: academic or other)
- Sponsor's past trials
- 43 (typical: 32)
- Sponsor's past termination rate
- 18.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 31 (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
- 2485 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 499 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- iron isomaltoside, 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
- Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement NCT03182751 · started 2018 · scored riskier than 90% of active trials completed
- A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty NCT03822793 · started 2023 · scored riskier than 96% of active trials completed
- Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population NCT03923959 · started 2020 · scored riskier than 36% of active trials completed
- Topical Tranexamic Acid (TXA) in Hip Fractures NCT02993341 · started 2016 · scored riskier than 25% of active trials completed
- Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia NCT03528564 · started 2019 · scored riskier than 61% of active trials terminated
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.