Platelet Transfusion in Critically Ill Patients With Thrombocytopenia
ConditionThrombocythemia
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Platelet transfusion if platelet count ≤ 10 G/L
Other interventionPlatelet transfusion as soon as platelet count falls ≤ 10 G/L
Platelet transfusion when platelet count ≤ 20 G/L
Other interventionPlatelet transfusion will be initiated immediately after randomisation
Treatment groups
536 Participants
are divided into 2 treatment groupsGroup A: Low-thresholdActive comparator 1 intervention
Group B: High thresholdExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of ICU-acquired severe and debilitating bleeding
Grades 3-4 of the modified WHO bleeding scale, assessed during the ICU stay, from the time of randomization to ICU discharge (or to the end of 28-day intervention period in patients remaining in the ICU after 28 days). Bleeding events will be collected up to 72h after ICU discharge. The modified WHO bleeding scale, commonly used in observational studies and trials to assess the severity of bleeding. It comprises 4 grades: grade 1 (minor blood loss), grade 2 (mild blood loss), grade 3 (severe blood loss (most often requiring Red Blood Cell transfusion) and grade 4 (debilitating blood loss).
Time frame
Until ICU discharge or up to 28 days in ICUSecondary outcomes
1
Incidence of ICU-acquired mild bleeding
WHO grade 2
Time frame
Until ICU discharge or at 28 days in ICU2
Incidence of ICU-acquired mild to debilitating bleeding
WHO grade 2-3-4
Time frame
Until ICU discharge or up to 28 days in ICU3
Total number of platelet transfusions episodes
Time frame
Until ICU discharge or up to 28 days in ICU4
Number of prophylactic platelet transfusions episodes
Time frame
Until ICU discharge or up to 28 days in ICULocations
Sponsors and contacts
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Source ClinicalTrials.gov
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