A randomised, placebo-controlled, double-blind study to investigate the efficacy and safety of rFVIIa as adjunctive therapy for control of bleeding in patients with severe blunt trauma: a re-analysis following the exclusion of early (< 48 hours) deaths
Bibliographic record
Abstract
Severely bleeding patients with blunt trauma were randomised to rFVIIa (200 + 100 + 100 μg/kg) or placebo as an adjunct to conventional treatment. Patients who had incurred both blunt and penetrating trauma were included in this study. First trial product injection followed the eighth RBC unit, with additional injections 1 hour and 3 hours later. The new efficacy analyses were performed on the patients surviving 48 hours or more after first administration of the trial product. Of 153 blunt trauma patients randomised, 117 were eligible for the primary efficacy analysis (10 patients were excluded because they did not receive the trial product due to death or arrest of bleeding before transfusion of the eighth unit of RBC, and 26 patients were excluded due to death within the 48-hour period). Total RBC transfusion was significantly reduced with rFVIIa relative to placebo (estimated reduction of 2.6 total RBC units; 90% confidence interval: [0.7; 4.6]; P = 0.02) (results previously presented). The need for massive transfusion (> 20 RBC units, inclusive of the eight predose units administered pre trial product) was significantly reduced: 8/56 patients (14%) with rFVIIa versus 20/61 patients (33%) with placebo ( P = 0.03), along with significant reductions in 48-hour requirements for FFP and platelets. The improved haemostasis was accompanied by a significant decrease in ARDS (3/56 [5%] of rFVIIa-treated vs 11/61 [18%] of placebo-treated patients [ P = 0.047]) as well as a significant decrease in the risk of developing organ failure (either MOF or ARDS: 5/56 [9%] of rFVIIa-treated vs 15/61 [25%] of placebo-treated patients [ P = 0.047]). Recombinant FVIIa improved clinical outcome (risk of developing single or multiple organ failure, especially ARDS) in severely bleeding blunt trauma patients. No safety issues were identified.
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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 | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| 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".