Self-Managed Long-Term Low-Molecular-Weight Heparin Therapy Compared with Usual-Care Anticoagulation for the Treatment of Patients with Proximal Venous Thrombosis: Harm Associated with Thrombocytopenia.
Bibliographic record
Abstract
Abstract Context: A substantial clinical need exists for an alternate to vitamin-K-antagonists for treating deep-vein thrombosis in many patients. Long-term low-molecular-weight heparin, body-weight adjusted, avoids anticoagulant monitoring and may be associated with less harm due to thrombocytopenia. Objective: Considerable evidence suggests that reporting of harms-related data* from randomized clinical trials needs improvement. In accordance with CONSORT* we present a harm analysis regarding thrombocytopenia. Design: Randomized clinical trial using objective outcome measures. Setting: 30 centres across Canada. Participants: Acute symptomatic proximal-vein thrombosis patients. Intervention: Therapeutic tinzaparin subcutaneously once-daily, or intravenous unfractionated heparin/oral vitamin-K-antagonist therapy for 3 months. Main Outcome Measures: Benefit was assessed by assessing the frequency of symptomatic objectively documented recurrent venous thromboembolism and harm by objectively documented hemorrhagic complications and the outcome of thrombocytopenia. Results: Benefit and bleeding harm are reported elsewhere. Long-term low-molecular-weight heparin treatment was at least as effective but associated with less harm due to bleeding than usual care. Thrombocytopenia occurred in 21 of 369 (5.7%) patients receiving tinzaparin versus 9 of 368 (2.4%) patients receiving usual care (absolute difference 3.3). Six of 9 patients with thrombocytopenia receiving usual care died (66.7 percent, 95 percent confidence interval 29.9 to 92.5) versus 4 of 21 with thrombocytopenia receiving low-molecular-weight heparin (19 percent, 95 percent confidence interval 5.4 to 41.9 percent) (absolute difference 47.6 percent, 95 percent confidence interval 82.7 to 12.5 percent, p=0.03). Recurrent venous thromboembolism occurred infrequently in patients with thrombocytopenia. Conclusion: Our findings suggest that harm associated with thrombocytopenia in patients receiving intravenous unfractionated heparin versus low-molecular-weight heparin favors low-molecular-weight heparin use. Further evaluation in rigorous trials is required.
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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 | 0.005 | 0.009 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".