Status:
NOT_YET_RECRUITING
Platelet Transfusion in Critically Ill Patients With Thrombocytopenia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Thrombocythemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 invasiv...
Eligibility Criteria
Inclusion
- 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)
- renal replacement therapy for metabolic disturbances and/or acute and acute-on chronic kidney failure (if not previously under chronic hemodialysis) AND
- Platelet count ≤ 20 G/L within the last 24h (first occurrence at any time during the ICU stay) AND
- expected ICU stay for at least 48 hours from the time of enrollment AND
- 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
- 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)
- 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…)
- Known full refractory status to platelet transfusion (prophylactic transfusion not recommended)
- Prophylactic platelet transfusion already applied at platelet count ≤ 20 G/L during the present ICU stay
- Patient opposed to transfusion of blood products
- Moribund patients (death expected within the next 24 hours)
- Pregnancy/breastfeeding
- Not covered by French Social Security (health insurance)
- Patient under safeguarding of justice
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT06599385
Start Date
November 1 2024
End Date
February 1 2028
Last Update
September 19 2024
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