Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

Phase 3

Not yet recruiting

• Conditions: Thrombocythemia
• Interventions: Other: Platelet transfusion if platelet count ≤ 10 G/L; Other: Platelet transfusion when platelet count ≤ 20 G/L

• Registration Number: NCT06599385
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Last Update Submitted: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-11-01
• Primary Completion: 2028-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 536

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-threshold	Platelet transfusion if platelet count ≤ 10 G/L	-
High threshold	Platelet transfusion when platelet count ≤ 20 G/L	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 ICU-acquired infections	Up to 72 hours after ICU discharge
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 Central Venous Catheter (CVC)-related hemorrhagic and infectious complications	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