Prospective pilot study of Floseal® for the treatment of anterior epistaxis in patients with hereditary hemorrhagic telangiectasia (HHT)
Bibliographic record
Abstract
Abstract Background Epistaxis is the most common symptom of hereditary hemorrhagic telangiectasia (HHT), affecting more than 98% of adults with HHT, with significant impact on quality of life. Floseal® has been shown to be effective for the management of anterior epistaxis, but has yet to be thoroughly evaluated in this population. Our goal was to evaluate the efficacy of Floseal® for managing acute anterior epistaxis in patients with HHT. Methods A pilot prospective clinical trial was conducted at two tertiary referral centres, St. Michael’s Hospital, Toronto, Canada and The Ottawa Hospital, Ottawa, Canada. All patients with HHT presenting with acute anterior epistaxis to the two study centres, who enrolled in the study, received Floseal® treatment. The primary outcome measures were achievement of hemostasis and changes in the Epistaxis Severity Score (ESS) between baseline and one-month follow up. Secondary outcome measure included clinical assessment of the nasal cavity. Results Seven patients were included in the final analysis. All patients underwent treatment of anterior epistaxis with Floseal® and achieved control of epistaxis within 15-min post-application. Application of Floseal® was well tolerated, with patients reporting a pain score of 3 ± 3.13 out of 10. There was no statistically significant difference noted in ESS scores pre-treatment and one-month follow up, 6.27 ± 2.42 vs. 4.50 ± 2.44, p = 0.179. There was a significant improvement clinically on exam of the nasal cavity between baseline and at one-month follow up, indicated by a decrease in the clinical assessment score, 17.29 ± 7.70 vs. 9.57 ± 7.81 (p = 0.0088). Conclusions Patients with HHT presenting with acute epistaxis were able to achieve hemostasis with one application of Floseal®, with the procedure being very well tolerated with minimal pain. Although there was no significant change in ESS scores, clinical assessment of the nasal cavity revealed significant improvement at one-month follow up post treatment with Floseal®. Trial registration This multi-centered prospective clinical trial was registered with ClinicalTrials.gov ( NCT02638012 ). Registered on December 22, 2015.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".