In-Vitro Stability of B-Domain Deleted Recombinant Factor VIII in Syringe-Based Continuous Infusion Devices.
Bibliographic record
Abstract
Abstract Continuous infusion (CI) factor VIII (FVIII) replacement is commonly used for serious bleeds in patients with FVIII deficiency. Clinicians lack stability information for Refacto®, a B-domain deleted recombinant FVIII (BDDrFVIII), when it is diluted or stored in CI devices for extended time periods. We studied BDDrFVIII to determine its concentration- and time-dependent stability and sterility when stored (reconstituted; reconstituted then diluted with normal saline) at ambient temperature in syringe-based CI devices (CADD-MicroTM; Baxter ColleagueTM). Three replicates of BDDrFVIII 125unit/mL and 25unit/mL admixtures were admixed aseptically then placed in CI devices that operated continuously for 48 hours. Samples (0.5ml) were obtained from control solutions (stored in the manufacturer’s glass vial) or expressed from the distal end of tubing at Hour −0.25 (priming volume), 0, 1, 2, 4, 8, 12, 24 and 48. Samples were stored at −70C until assayed for Factor VIII activity using a 1-stage automated assay and Refacto® [chromogenic equivalent] Standard. Results of FVIII assays for each trio of replicates were averaged. BDDrFVIII admixtures were considered stable if they retained ≥80% baseline (control) FVIII values. Recoveries for BDDrFVIII 125unit/mL admixtures remained stable and sterile for 48 hours when stored in the manufacturer’s glass vial, Baxter ColleagueTM or CADD MicroTM devices, sufficient for clinical use (Table). BDDrFVIII, when diluted to 25unit/mL, remained sterile but not stable when stored in Baxter ColleagueTM or CADD MicroTM devices, and is not recommended for CI in clinical settings. Loss of FVIII activity in BDDrFVIII 25unit/mL admixtures is thought to be due to binding of BDDrFVIII to device components. %FVIII Activity of BDDrFVIII Stored in Infusion Devices Hr 0 Hr 1 Hr 2 Hr 4 Hr 12 Hr 24 Hr 48 Mfr Glass Vial (Control) 92.5 93 90.7 90.8 93.2 76 80.7 CADD-Micro 125unit/ml 80 84 86.3 78.3 86.3 80 81.7 Baxter Colleague 125unit/ml 86.3 79 74 85 77.7 81 82.3 CADD-Micro 25unit/ml 65.7 61.3 56.3 59 57.5 59.7 56.3 Baxter Colleague 25unit/ml 18.7 19.3 33 24.3 27 27 27.3
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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 | 0.002 |
| 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 | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".