Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 y.o. AND

Hospitalisation in the ICU with at least one of the following life support during the current ICU stay (past or ongoing, regardless of indications)

circulatory support (inotropes/ vasopressors at any dose)

respiratory support (invasive mechanical ventilation, non-invasive ventilation, continuous positive airway pressure (CPAP), high-flow nasal oxygen, O2 supply ≥ 6 L/min)

Disqualifiers

Major bleeding (WHO grade 3-4) or mild bleeding (WHO grade 2) within the present hospitalization

Major surgery within the recent 72 hours

Intracranial or retinal bleeding within the recent 7 days

Non- or contra-indication to prophylactic platelet transfusion (immune thrombocytopenia, thrombotic microangiopathy)

Trial design

Treatments tested in this trial

  • Platelet transfusion if platelet count ≤ 10 G/L
  • Platelet transfusion when platelet count ≤ 20 G/L

Treatment groups

536 Participants
are divided into 2 treatment groups

Locations

This trial has no locations