U.S. Factor XI Patients: Is There a Safer Treatment? Yes - Hemoleven.
Bibliographic record
Abstract
Abstract Despite donor screening and newer PCR testing, human-derived fresh frozen plasma (FFP) is not without the potential for viral transmission. Factor XI-deficient patients are plentiful in the U.S. (estimate ~1500–2000). Although there is discordance between phenotype and genotype, with substantially fewer “bleeders” than those with deficiency, and spontaneous bleeding is rare, surgical intervention frequently demands replacement therapy. The English F XI concentrate, virally inactivated, had thrombosis as a complication, and heparin was added, but is no longer available in the U.S. An LFB factor XI concentrate (Hemoleven), doubly viral-inactivated, with heparin and ATIII is available internationally, but not in the U.S. A review of 56 cases treated in France, Spain, Switzerland, Canada, and Israel reveal that for minor and major surgery it is both safe and effective. Between 1992 and 2004, data for the use of Hemoleven for either prophylaxis, minor and major surgery was collected. In all, hemostasis was excellent. In three, concentrate was used because of anaphylaxis with FFP. Three had laboratory evidence of DIC and, of these, one had a PE. In addition, these three cases received excessive dosage. Twelve patients had recovery and half-life studies for this concentrate. T1/2 was 45.5 ± 7.9h and recovery was 1.85 ± 0.38%/u/kg. These data are evidence that a safer and effective therapy for F XI patients exist outside of the U.S. We should not have to wait for a new infectious agent transmitted by FFP before we make it available in the U.S.. We should have learned something from HIV, when DDAVP was used everywhere, but not licensed here.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 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".