NCT06599385

Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 536 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocythemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2024-09-19
• Last updated: 2024-09-19