Clinical trial NCT06599385: Platelet Transfusion in Critically Ill Patients With Thrombocytopenia
Official title: Platelet Transfusion in Critically Ill Patients With Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Thrombocythemia
Keywords: Platelet transfusion
Thrombocythemia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective non-inferiority open-label randomised trial with two comparative groups
Primary purpose: PREVENTION

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 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: 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 \&gt; 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

Primary outcomes:
measure: Incidence of ICU-acquired severe and debilitating bleeding
timeFrame: Until ICU discharge or up to 28 days in ICU
Secondary outcomes:
measure: Incidence of ICU-acquired mild bleeding
timeFrame: Until ICU discharge or at 28 days in ICU
measure: Incidence of ICU-acquired mild to debilitating bleeding
timeFrame: Until ICU discharge or up to 28 days in ICU
measure: Total number of platelet transfusions episodes
timeFrame: Until ICU discharge or up to 28 days in ICU
measure: Number of prophylactic platelet transfusions episodes
timeFrame: Until ICU discharge or up to 28 days in ICU
measure: Doses of transfused platelets
timeFrame: Until ICU discharge or up to 28 days in ICU
measure: Number of packed red cell transfusions
timeFrame: Until ICU discharge or up to 28 days in ICU
measure: Volumes of packed red cell transfusions
timeFrame: Until ICU discharge or up to 28 days in ICU
measure: Volumes of fresh frozen plasma
timeFrame: Until ICU discharge or up to 28 days in ICU
measure: Incidence of ICU-acquired infections
timeFrame: Up to 72 hours after ICU discharge
measure: Incidence of acquired arterial thrombotic events
timeFrame: Up to 72 hours after ICU discharge
measure: Incidence of acquired venous thrombotic events
timeFrame: Up to 72 hours after ICU discharge
measure: Incidence of Central Venous Catheter (CVC)-related hemorrhagic and infectious complications
timeFrame: Up to 72 hours after ICU discharge
measure: Incidence of platelet transfusion-related side effects
timeFrame: Up to 72 hours after ICU discharge
measure: Incidence of transfusion-related pulmonary manifestations (acute pulmonary oedema and acute lung injury (TRALI))
timeFrame: Up to 72 hours after ICU discharge
measure: Incidence of anti-HLA/HPA immunization
timeFrame: Up to 72 hours after ICU discharge
measure: In ICU survival
timeFrame: Up to 90 days
measure: In hospital survival
timeFrame: Up to 90 days
measure: 28 day survival
timeFrame: At 28 days
measure: In ICU length of stay
timeFrame: Up to 90 days
measure: In hospital length of stay
timeFrame: Up to 90 days
measure: 90-day survival
timeFrame: Up to 90 days
measure: 90-day hospital costs
timeFrame: Up to 90 days
Other outcomes:
Locations:
Study officials:
References: