Platelet Transfusion Thresholds for Children Supported by Extracorporeal Membrane Oxygenation: The Extracorporeal Membrane Oxygenation Hemostatic Transfusions in Children (ECSTATIC) Feasibility Clinical Trial
Bibliographic record
Abstract
OBJECTIVES: To evaluate the feasibility of randomizing children on extracorporeal membrane oxygenation (ECMO) to one of two prophylactic platelet transfusion thresholds. DESIGN: Randomized controlled trial. SETTING: Ten ECMO centers (nine in United States, one in Israel). PATIENTS: Critically ill children (0 to younger than 18 yr), supported on ECMO, with no or minimal bleeding within 24 hours of cannulation. INTERVENTIONS: Children were randomized to a higher platelet threshold (transfused when platelet count < 90 × 10 9 /L) or a lower platelet threshold (transfused when platelet count < 50 × 10 9 /L). Primary feasibility outcome was pre-transfusion platelet count to test for a difference between strategies. Primary safety outcome was progression to severe bleeding, severe clotting, and/or all-cause mortality. MEASUREMENTS AND MAIN RESULTS: Of 159 patients screened for eligibility, 77% (123/159) met eligibility criteria. Sixty-five percent (80/123) of caregivers were approached for consent. Consent was obtained in 63% (50/80). Enrolled children had a median age of 0.2 years (interquartile range 0.0; 1.7) and 88% (44/50) were supported by veno-arterial (V-A) ECMO. The model-adjusted mean difference in pre-transfusion platelet count between the groups was 32 × 10 9 /L ( p < 0.001). Compliance with assigned transfusion threshold was 99.2%. Eleven (22%) children experienced the primary safety outcome. Progression to severe bleeding occurred in 14% (7/50) of patients, whereas progression to severe clotting was observed in 4% (2/50). CONCLUSIONS: Non-bleeding children on ECMO can be screened, enrolled and randomized to different platelet transfusion strategies within 24 hours of cannulation. Compliance with the protocol was excellent with significant separation in pre-transfusion platelet counts between the arms. Severe bleeding and severe clotting occurred at similar rates in both thresholds. A larger, definitive trial is feasible and needed.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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) | 0.003 | 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".