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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-threshold | Active Comparator |
| |
| High threshold | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet transfusion if platelet count ≤ 10 G/L | Other | Platelet transfusion as soon as platelet count falls ≤ 10 G/L |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Until ICU discharge or up to 28 days in ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ICU-acquired mild bleeding | WHO grade 2 | Until ICU discharge or at 28 days in ICU |
| Incidence of ICU-acquired mild to debilitating bleeding | WHO grade 2-3-4 |
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Inclusion Criteria:
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)
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédéric Pene, MD PhD | Contact | 0158414677 | +33 | frederic.pene@aphp.fr |
| Jérôme Lambert, MD PhD | Contact | 0142499742 | +33 | jerome.lambert@u-paris.fr |
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| ID | Term |
|---|---|
| D013922 | Thrombocytosis |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
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Prospective non-inferiority open-label randomised trial with two comparative groups
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| Platelet transfusion when platelet count ≤ 20 G/L | Other | Platelet transfusion will be initiated immediately after randomisation |
|
| Until ICU discharge or up to 28 days in ICU |
| 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 ICU-acquired infections | Up to 72 hours after ICU discharge |
| Incidence of acquired arterial thrombotic events | Acute coronary syndrome, acute limb ischemia, mesenteric ischemia, stroke | Up to 72 hours after ICU discharge |
| Incidence of acquired venous thrombotic events | Thrombophlebitis and pulmonary embolism | Up to 72 hours after ICU discharge |
| Incidence of Central Venous Catheter (CVC)-related hemorrhagic and infectious complications | Up to 72 hours after ICU discharge |
| Incidence of platelet transfusion-related side effects | Any significant transfusion reaction such as chills and fever or side effect requiring to be reported to the local hemovigilance system | Up to 72 hours after ICU discharge |
| 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 | Investigated in case of platelet transfusion refractoriness | Up to 72 hours after ICU discharge |
| In ICU survival | Investigated in case of platelet transfusion refractoriness | Up to 90 days |
| In hospital survival | Investigated in case of platelet transfusion refractoriness | Up to 90 days |
| 28 day survival | Investigated in case of platelet transfusion refractoriness | At 28 days |
| 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 | From randomization to day 90 | Up to 90 days |
| D001855 | Bone Marrow Diseases |