Challenges in Trials in Sickle Cell Disease: Thromboprophylaxis in Sickle Cell Disease With Central Venous Catheters ( <scp>THIS</scp> ) Pilot Study
Bibliographic record
Abstract
Individuals with sickle cell disease (SCD) often require central venous catheter (CVC) use; however, this is associated with a high incidence of venous thromboembolism (VTE). We conducted a pilot randomized controlled trial (RCT) to assess if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to placebo as thromboprophylaxis in adult SCD participants with CVC. In this pilot investigator-initiated, double-blinded, multi-center RCT, we assessed feasibility outcomes to explore if a full RCT is possible, and also exploratory outcomes of thrombosis and bleeding. THIS pilot trial was closed prematurely due to slow recruitment, lack of funding, and non-feasibility of the complete trial. Of 21 participants who met eligibility criteria, 4 were recruited into the study. Adherence to study procedures was 100% and loss to follow-up was 0%. One participant was noted to have a VTE during follow-up, but of unknown chronicity. Another participant developed a new VTE post-randomization, but prior to starting study drug. No major or clinically relevant bleeding events occurred during study follow-up. Challenges in running the study were largely due to a limited eligible population, and low participation interest in study involvement. Trial Registration: ClinicalTrials.gov identifier: NCT05033314.
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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 | 0.175 | 0.174 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.004 | 0.005 |
| Open science | 0.002 | 0.003 |
| Research integrity | 0.006 | 0.007 |
| Insufficient payload (model declined to judge) | 0.014 | 0.003 |
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".