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NOT YET RECRUITING
NCT06599385
PHASE3

Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Thrombocytopenia is a common biological disorder in critically ill patients. The main supportive treatment is platelet transfusion with the aim of preventing and treating bleeding and securing invasive procedures. Current guidelines suggest that prophylactic platelet transfusion should probably be administered in non-bleeding critically ill patients at platelet count triggers of 10 to 20 G/L, albeit with very low certainty since extrapolated from studies carried out in stable patients with hematological malignancies. Indications for prophylactic platelet transfusion have not been properly addressed in adult ICU patients with regard to their particular risk of bleeding and prognosis. We propose the TRAMPOLINE study in order to address two different platelet count thresholds of 10 G/L (low threshold) or 20 G/L (high threshold) for the prevention of ICU-acquired bleeding in critically ill patients with severe thrombocytopenia.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

536

Start Date

2024-11-01

Completion Date

2028-02-01

Last Updated

2024-09-19

Healthy Volunteers

No

Conditions

Interventions

OTHER

Platelet transfusion if platelet count ≤ 10 G/L

Platelet transfusion as soon as platelet count falls ≤ 10 G/L

OTHER

Platelet transfusion when platelet count ≤ 20 G/L

Platelet transfusion will be initiated immediately after randomisation