Thrombocythemia
Conditions
Keywords
Platelet transfusion, Thrombocythemia
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.
Interventions
OTHERPlatelet transfusion if platelet count ≤ 10 G/L
Platelet transfusion as soon as platelet count falls ≤ 10 G/L
OTHERPlatelet transfusion when platelet count ≤ 20 G/L
Platelet transfusion will be initiated immediately after randomisation
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective non-inferiority open-label randomised trial with two comparative groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ICU-acquired severe and debilitating bleeding | Until ICU discharge or up to 28 days in ICU | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ICU-acquired mild bleeding | Until ICU discharge or at 28 days in ICU | WHO grade 2 |
| Incidence of ICU-acquired mild to debilitating bleeding | Until ICU discharge or up to 28 days in ICU | WHO grade 2-3-4 |
| Total number of platelet transfusions episodes | Until ICU discharge or up to 28 days in ICU | — |
| Number of prophylactic platelet transfusions episodes | Until ICU discharge or up to 28 days in ICU | — |
| Doses of transfused platelets | Until ICU discharge or up to 28 days in ICU | — |
| Number of packed red cell transfusions | Until ICU discharge or up to 28 days in ICU | — |
| Volumes of packed red cell transfusions | Until ICU discharge or up to 28 days in ICU | — |
| Volumes of fresh frozen plasma | Until ICU discharge or up to 28 days in ICU | — |
| Incidence of acquired arterial thrombotic events | Up to 72 hours after ICU discharge | Acute coronary syndrome, acute limb ischemia, mesenteric ischemia, stroke |
| Incidence of acquired venous thrombotic events | Up to 72 hours after ICU discharge | Thrombophlebitis and pulmonary embolism |
| Incidence of ICU-acquired infections | Up to 72 hours after ICU discharge | — |
| Incidence of platelet transfusion-related side effects | Up to 72 hours after ICU discharge | Any significant transfusion reaction such as chills and fever or side effect requiring to be reported to the local hemovigilance system |
| Incidence of transfusion-related pulmonary manifestations (acute pulmonary oedema and acute lung injury (TRALI)) | Up to 72 hours after ICU discharge | — |
| Incidence of anti-HLA/HPA immunization | Up to 72 hours after ICU discharge | Investigated in case of platelet transfusion refractoriness |
| In ICU survival | Up to 90 days | Investigated in case of platelet transfusion refractoriness |
| In hospital survival | Up to 90 days | Investigated in case of platelet transfusion refractoriness |
| 28 day survival | At 28 days | Investigated in case of platelet transfusion refractoriness |
| In ICU length of stay | Up to 90 days | — |
| In hospital length of stay | Up to 90 days | — |
| 90-day survival | Up to 90 days | — |
| 90-day hospital costs | Up to 90 days | From randomization to day 90 |
| Incidence of Central Venous Catheter (CVC)-related hemorrhagic and infectious complications | Up to 72 hours after ICU discharge | — |
Contacts
Primary ContactFrédéric Pene, MD PhD
Backup ContactJérôme Lambert, MD PhD
Outcome results
None listed