SP481DALTEPARIN SODIUM FOR THE PREVENTION OF CLOTTING IN THE EXTRACORPOREAL CIRCUIT DURING HEMODIALYSIS: A PHASE IIIB OPEN-LABEL STUDY TO OPTIMIZE A SINGLE BOLUS DOSE—THE PARROT STUDY
Bibliographic record
Abstract
INTRODUCTION AND AIMS: Dalteparin sodium, a low-molecular weight heparin (LMWH), is indicated for prevention of clotting in the extracorporeal system during hemodialysis (HD). Product labelling recommends a fixed, single bolus dose of 5000 international units (IU) for HD sessions lasting <4 hours. However, flexible dosing above or below 5000 IU may be beneficial. The aim of this study was to investigate the safety and efficacy of dalteparin sodium during HD, using a flexible-dose regimen. METHODS: This was a single-arm study of patients with chronic renal failure who require 3-4 HD sessions per week lasting up to 4 hours per session, previously receiving unfractionated heparin or LMWHs. Participants received a bolus of dalteparin sodium 5000 IU, administered into the arterial side of the dialysis circuit. Dalteparin sodium dose could be adjusted (+/- 500 or 1000 IU) at subsequent HD sessions (<20 sessions) when clinically indicated, with no specified dose limits. The primary efficacy endpoint was the proportion of successful HD sessions, defined as an HD session that was conducted without termination due to clotting. Fixed and flexible dosing regimens were compared using a split-sample statistical approach. RESULTS: Of a total 2827 HD sessions (152 participants; mean age, 57.1 years; 69.7% male), 2776 (98.2%) were evaluable for efficacy, and 2774 were successful (99.9%; [95% CI: 99.7, 100]). A total of 79 participants (52.3%) received ≥1 dose adjustment (average dose, 5488 IU; range, 500-13,000 IU), mostly due to clotting or access compression time >10 minutes. The median difference in the proportion of successful HD sessions between the fixed and flexible dosing regimens was −0.1% (95% CI: −0.3%, 0.1%). Grade 3 and 4 clotting occurred in 402 (14.5%) and 77 (2.8%) HD sessions, respectively. Of 2818 (99.7%) HD sessions evaluable for safety, 65 (2.3%) were associated with minor bleeding, and 1 (0.04%) with a clinically relevant non-major bleed. There were no major bleeds or deaths reported during the study. CONCLUSIONS: A flexible dalteparin sodium dosing regimen was safe and effective in patients with chronic renal failure requiring 3-4 HD session per week, and may have clinical benefits over the standard fixed-dose regimen for preventing clotting in the extracorporeal circuit during HD.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".