Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

Phase 3Not Yet RecruitingNCT06599385

Assistance Publique - Hôpitaux de Paris536 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

536

Conditions

Thrombocythemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 ICU

Secondary Outcomes

Incidence of ICU-acquired mild bleeding

WHO grade 2

Time frame: Until ICU discharge or at 28 days in ICU

Incidence of ICU-acquired mild to debilitating bleeding

WHO grade 2-3-4

Time frame: Until ICU discharge or up to 28 days in ICU

Total number of platelet transfusions episodes

Time frame: Until ICU discharge or up to 28 days in ICU

Number of prophylactic platelet transfusions episodes

Time frame: Until ICU discharge or up to 28 days in ICU

Doses of transfused platelets

Time frame: Until ICU discharge or up to 28 days in ICU

Number of packed red cell transfusions

Time frame: Until ICU discharge or up to 28 days in ICU

Volumes of packed red cell transfusions

Time frame: Until ICU discharge or up to 28 days in ICU

Volumes of fresh frozen plasma

Time frame: Until ICU discharge or up to 28 days in ICU

Incidence of ICU-acquired infections

Time frame: Up to 72 hours after ICU discharge

Incidence of acquired arterial thrombotic events

Acute coronary syndrome, acute limb ischemia, mesenteric ischemia, stroke

Time frame: Up to 72 hours after ICU discharge

Incidence of acquired venous thrombotic events

Thrombophlebitis and pulmonary embolism

Time frame: Up to 72 hours after ICU discharge

Incidence of Central Venous Catheter (CVC)-related hemorrhagic and infectious complications

Time frame: 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

Time frame: Up to 72 hours after ICU discharge

Incidence of transfusion-related pulmonary manifestations (acute pulmonary oedema and acute lung injury (TRALI))

Time frame: Up to 72 hours after ICU discharge

Incidence of anti-HLA/HPA immunization

Investigated in case of platelet transfusion refractoriness

Time frame: Up to 72 hours after ICU discharge

In ICU survival

Investigated in case of platelet transfusion refractoriness

Time frame: Up to 90 days

In hospital survival

Investigated in case of platelet transfusion refractoriness

Time frame: Up to 90 days

28 day survival

Investigated in case of platelet transfusion refractoriness

Time frame: At 28 days

In ICU length of stay

Time frame: Up to 90 days

In hospital length of stay

Time frame: Up to 90 days

90-day survival

Time frame: Up to 90 days

90-day hospital costs

From randomization to day 90

Time frame: Up to 90 days

Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts