NCT06599385Not yet recruitingPhase 3
Platelet Transfusion in Critically Ill Patients With Thrombocytopenia
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 536 (estimated)
- First submitted
- 13 Sept 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- NCT number
- NCT06599385
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 536
- From 1 Nov 2024 to the primary completion date, 1 Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within the recent 72 hours
Other illness
- Major bleeding (WHO grade 3-4) or mild bleeding (WHO grade 2) within the present hospitalization
- Intracranial or retinal bleeding within the recent 7 days
Lab values
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.