In vitro stability and compatibility of tenecteplase in central venous access devices
Bibliographic record
Abstract
Central venous access devices (CVADs) aid in the delivery of nutritional support, infusion therapy, and hemodialysis. Maintaining continuous flow through these devices is challenging, because they are susceptible to complications such as thrombi occlusion. Therefore, CVADs may require treatment with anticoagulant or thrombolytic agents. Using these agents as locking solutions has been widely investigated; however, few publications have described the compatibility of the therapeutic with the CVAD itself. The objective of this investigation was to evaluate the in vitro stability and compatibility of a thrombolytic biologic agent, tenecteplase, with various CVAD materials. Tenecteplase was reconstituted to 1 mg/mL with either sterile water for injection or bacteriostatic water for injection (0.9% benzyl alcohol) then incubated in glass vials, polysulfone/silicone vascular access ports, and polyurethane or silicone catheters for up to 96 hours. Biochemical assays including protein monomer, protein one-chain, and in vitro bioactivity were used to assess tenecteplase's compatibility with the investigated diluents and materials every 24 hours. Antimicrobial testing was also performed for up to 28 days on bacteriostatic water for injection-reconstituted samples only. Our results showed tenecteplase to be compatible with both types of diluents (in glass vials) and catheters for up to 72 hours. Furthermore, tenecteplase was compatible with the polysulfone/silicone vascular access ports for up to 24 hours. Finally, bacteriostatic water for injection-reconstituted tenecteplase effectively met USP criteria for the inhibition of growth of micro-organisms. This study serves as an example of a best practice to evaluate the in vitro stability and compatibility of a biologic agent with CVAD materials.
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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 | 0.000 |
| 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".