Strategies for anticoagulation in patients with thrombocytopenia and cancer-associated thrombosis (START): design and rationale of the START pilot randomized controlled trial
Bibliographic record
Abstract
Patients with cancer have high risks of venous thromboembolism (VTE) as well as thrombocytopenia. Thrombocytopenia is associated with an increased risk of bleeding. Hence, treatment of acute VTE with anticoagulation is challenging in patients with cancer and thrombocytopenia. Data are limited in the management of this condition, and there are no randomized controlled trials (RCTs) available. The strategies for anticoagulation in patients with thrombocytopenia and cancer-associated thrombosis pilot trial (NCT05255003) is an open-label pilot RCT to evaluate the feasibility of a full-scale trial in this population. Adult patients with acute cancer-associated thrombosis within 14 days and thrombocytopenia (platelet count < 50,000/μL) are randomly assigned to 2 treatment arms as follows: (1) modified-dose low-molecular-weight heparin based on a predefined regimen to adjust dose by platelet count; or (2) platelet transfusion with a higher dose low-molecular-weight heparin regimen. The primary feasibility outcome is the overall average number of patients recruited per month. The main clinical outcomes include clinically relevant bleeding events (composite of major bleeding and clinically relevant nonmajor bleeding) and objectively confirmed recurrent VTE. This trial has the potential to define care in patients with acute cancer-associated thrombosis and thrombocytopenia. In this article, we present the rationale and design of the pilot trial and highlight several unique aspects of the study.
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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 | 0.036 | 0.036 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.005 | 0.004 |
| Insufficient payload (model declined to judge) | 0.011 | 0.002 |
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".