Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 13, 2024

Keywords

ClinConnect Summary

The TRAMPOLINE study is a clinical trial designed to understand the best approach for using platelet transfusions in critically ill patients who have a low platelet count, a condition known as thrombocytopenia. Platelets are important for helping blood to clot, and when patients have very few of them, they are at risk for bleeding. This trial will compare two different platelet count levels—10 G/L and 20 G/L—to determine which threshold might be more effective in preventing bleeding in patients who are in the Intensive Care Unit (ICU).

To participate in this study, individuals must be at least 18 years old, currently hospitalized in the ICU, and have a low platelet count of 20 G/L or less. They should also be receiving some form of life support, such as help with breathing or circulation. Participants can expect to receive platelet transfusions if their platelet counts meet the study criteria and will be monitored for any bleeding complications. It's important to note that patients with certain conditions, like major bleeding or recent major surgery, may not be eligible for this trial. If you or a loved one are interested in participating, please consult with the healthcare team for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 y.o. AND
• • 2. 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)
• • renal replacement therapy for metabolic disturbances and/or acute and acute-on chronic kidney failure (if not previously under chronic hemodialysis) AND
• • 3. Platelet count ≤ 20 G/L within the last 24h (first occurrence at any time during the ICU stay) AND
• • 4. expected ICU stay for at least 48 hours from the time of enrollment AND
• • 5. Signed consent by the patient or his/her relative, or under an emergency procedure (emergency enrollment notified in the medical file, with requirement for confirmation consent a posteriori)
• Exclusion Criteria:
• • 1. Major bleeding (WHO grade 3-4) or mild bleeding (WHO grade 2) within the present hospitalization
• • 2. Major surgery within the recent 72 hours
• • 3. Intracranial or retinal bleeding within the recent 7 days
• • 4. Non- or contra-indication to prophylactic platelet transfusion (immune thrombocytopenia, thrombotic microangiopathy)
• • 5. Indications for increased prophylactic platelet transfusion threshold \> 20 G/L (conditions associated with increased risk of bleeding including, but not limited to extra-corporeal membrane oxygenation, therapeutic anticoagulant treatment, fibrinolysis...)
• • 6. Known full refractory status to platelet transfusion (prophylactic transfusion not recommended)
• • 7. Prophylactic platelet transfusion already applied at platelet count ≤ 20 G/L during the present ICU stay
• • 8. Patient opposed to transfusion of blood products
• • 9. Moribund patients (death expected within the next 24 hours)
• • 10. Pregnancy/breastfeeding
• • 11. Not covered by French Social Security (health insurance)
• • 12. Patient under safeguarding of justice