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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".